II Ring Retractor
Pelvic Surgical Retractor System ; Vaginal Surgical Retractor System 50-4692 with 1"x4" Malleable blades Table Post 12", 1" Post Coupling, Horizontal Flex Bar, 6 Tilt Ratchet Mechanisms,…
Pelvic Surgical Retractor System ; Vaginal Surgical Retractor System 50-4692 with 1″x4″ Malleable blades Table Post 12″, 1″ Post Coupling, Horizontal Flex Bar, 6 Tilt Ratchet Mechanisms, Vaginal Segmented Ring 9.5″ x 13.5″ Retractors: Lateral Vaginal 1″ x 3″, Vaginal Posterior 1″ x 4.5″, Deaver Small 1″ x 3.5″, Deaver Large 1″ x 5″ 2 Malleable 1″ x 4″ with protected edge, 2 Super Malleable 1″ x 4″ with protected edge
34manufacturers in China registered for this device type
174catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Automated Medical Products Corp., United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Kelly 2″ x 3″ Retractor Aluminum/Radiolucent | In distribution | |
| Rake 4-Prong with Rotation 3/4” x 7/8” | In distribution | |
| Standard Ratchet Mechanism | In distribution | |
| St. Mark’s Retractor 11″ with Lip | In distribution | |
| Harrington Retractor 3 1/2″ x 10″ x 4 1/2″ | In distribution | |
| Segmented Elliptical Ring 14” x 15” | In distribution | |
| Oval Ring Medium 10.5” x 14.5” | In distribution | |
| Hook Scoville Retractor Large 3” Titanium/Radiolucent | In distribution | |
| Malleable Retractor 1/2″ x 4″ with Protective. Edge | In distribution | |
| Segmented Round Ring Medium 10.5” Diameter | In distribution | |
| IMA Hook | In distribution | |
| Kelly Retractor 2″ x 6″ | In distribution | |
| Segmented Round Ring Small 8.5” Diameter | In distribution | |
| Hook Urology, Single Prong | In distribution | |
| IMA Cross-bar 12″ | In distribution | |
| Malleable (Super) Retractor 1″ x 4″ with Protective Edge | In distribution | |
| Skin Rake Retractor 3-Prong 2/3″ W x 3/4″ D Titanium/Radiolucent | In distribution | |
| Kelly Retractor 2″ x 1 1/2″ | In distribution | |
| Table Post 24” (60 cm) | In distribution | |
| Malleable Retractor 6″ x 12″ with Protective Edge | In distribution | |
| Richardson Retractor 1″ x 1 1/2″ | In distribution | |
| Malleable Retractor 3″ x 10″ with Protective Edge | In distribution | |
| Meyerding Retractor Small with Teeth 2/3” x 2 1/3” Titanium/Radiolucent | In distribution | |
| Hook Scoville Retractor Large 3” | In distribution | |
| Balfour Swivel Retractor 3 1/4″ x 2 1/4″ Aluminum/Radiolucent | In distribution | |
| Malleable Retractor 2″ x 8″ with Protective Edge | In distribution | |
| Hook Scoville Retractor Small 2” | In distribution | |
| Lateral Vaginal Retractor 1″ x 3″ | In distribution | |
| Rectal Retractor Small 7/8” x 3 7/8” | In distribution | |
| Ratchet Extender | In distribution | |
| Meyerding Retractor Small 2/3” x 2 1/3” NO Teeth | In distribution | |
| Meyerding Retractor Medium 1” x 3 1/3” with Teeth | In distribution | |
| Segmented Oval Ring Medium 10.5″ x 19″ | In distribution | |
| Wylie Vein Retractor 1” x 4” | In distribution | |
| Skin Rake Retractor 6-Prong 1″ W x 1/3″ D | In distribution | |
| Malleable Retractor 1″ x 5″ with Protective Edge | In distribution | |
| Wylie Vein Retractor 1” x 4” Aluminum/Radiolucent | In distribution | |
| Malleable Retractor 3″ x 6″ with Protective Edge | In distribution | |
| Balfour Swivel Retractor 2 1/2″ x 2 3/4″ Aluminum/Radiolucent | In distribution | |
| Kelly 1″ x 3″ Retractor Aluminum/Radiolucent | In distribution | |
| Balfour Swivel Retractor 4″ x 2 1/4″ Aluminum/Radiolucent | In distribution | |
| Oval Ring Large 12” x 18.5” | In distribution | |
| Big Boy Retractor 3” x 6 1/2” | In distribution | |
| Kelly 1″ x 6″ Retractor Aluminum/Radiolucent | In distribution | |
| Replacement Screw for all Segmented Rings | In distribution | |
| Kelly Retractor 2″ x 3″ | In distribution | |
| Malleable Retractor 3/4″ x 4″ with Protective Edge | In distribution | |
| Vertical Extension Bar 12” x 1” | In distribution | |
| Richardson Retractor 3/4″ x 2″ | In distribution | |
| Richardson Retractor 3/4″ x 1″ | In distribution | |
| Wylie Vein Retractor 1” x 6” Aluminum/Radiolucent | In distribution | |
| Meyerding Retractor Large 2” x 3 3/4” NO Teeth Titanium/Radiolucent | In distribution | |
| St. Mark’s Retractor 5″ with Lip | In distribution | |
| Balfour Retractor 3″ x 2 5/8″ | In distribution | |
| Balfour Retractor 2″ x 2″ | In distribution | |
| Straight Segments Large 8” Sold in Pairs | In distribution | |
| Right Angled Retractor 1/2” x 1 1/2″ | In distribution | |
| Deaver Retractor 1” x 7” | In distribution | |
| Kelly Retractor 2.5″ x 10″ | In distribution | |
| Malleable Retractor 3″ x 7″ with Protective Edge | In distribution | |
| Kelly Retractor 2.5″ x 7″ | In distribution | |
| Right Angled Retractor 1/2” x 1″ | In distribution | |
| Skin Rake Retractor 6-Prong 1″ W x 1/3″ D Titanium/Radiolucent | In distribution | |
| Malleable Retractor 1″ x 4″ with Protective Edge | In distribution | |
| Meyerding Retractor Medium 1” x 3 1/3” NO Teeth | In distribution | |
| Rectal Retractor Large 7/8” x 2 7/8” | In distribution | |
| Kelly Retractor 2″ x 4″ Titanium/Radiolucent | In distribution | |
| Meyerding Retractor Medium 1” x 3 1/3” NO Teeth Titanium/Radiolucent | In distribution | |
| Richardson Retractor 1″ x 1 1/4″ | In distribution | |
| Post Coupling 1” to 1” | In distribution | |
| Kelly Retractor 2″ x 8″ | In distribution | |
| Six Finger Fence Malleable Retractor with Protected Edge, 5” Tines | In distribution | |
| Malleable Retractor 4″ x 10″ with Protective Edge | In distribution | |
| Skin Rake Retractor 3-Prong 2/3″ W x 3/4″ D | In distribution | |
| St. Mark’s Retractor 6″ with Lip | In distribution | |
| Wylie Vein Retractor 1” x 7” Aluminum/Radiolucent | In distribution | |
| Segmented Oval Ring Large 12.5″ x 19″ | In distribution | |
| Segmented Perineal Ring Notched 9.5” x 13.5” | In distribution | |
| Balfour Swivel Retractor 4 1/2″ x 2 1/2″ Aluminum/Radiolucent | In distribution | |
| Carroll Prostate Malleable Retractor 1 1/2″ to 3 1/4″ x 7″ | In distribution | |
| Universal Hand Held Adapter for Ring Style Retractors | In distribution | |
| Harrington Retractor 1″ x 5 5/8″ x 2 1/2″ | In distribution | |
| Yu-Holtgrewe Malleable Retractor 2″ W x 6 1/8” D | In distribution | |
| Oval Ring Small 8” x 12.5” | In distribution | |
| Meyerding Retractor Large with Teeth 2” x 3 3/4” Titanium/Radiolucent | In distribution | |
| Posterior Vaginal Retractor 1″ x 4 1/2″ | In distribution | |
| Malleable Retractor 3″ x 12″ with Protective Edge | In distribution | |
| Malleable Retractor 2″ x 12″ with Protective Edge | In distribution | |
| Pelvic Surgery System w 1×4″ Maleable Blades | In distribution | |
| Malleable Retractor 3″ x 8″ with Protective Edge | In distribution | |
| Deaver Retractor 1” x 5” | In distribution | |
| Wylie Vein Retractor 1” x 6” | In distribution | |
| Kelly 1″ x 4″ Retractor Aluminum/Radiolucent | In distribution | |
| Kelly 2″ x 6″ Retractor Aluminum/Radiolucent | In distribution | |
| Kelly Retractor 2″ x 8″ Titanium/Radiolucent | In distribution | |
| Deaver Retractor 2/3” x 2 1/4” | In distribution | |
| Tilt Ratchet Mechanism | In distribution | |
| Big Boy Retractor 2” x 6 1/2” | In distribution | |
| Malleable Retractor 1″ x 9″ with Protective Edge | In distribution | |
| Meyerding Retractor Small 2/3” x 2 1/3” NO Teeth Titanium/Radiolucent | In distribution | |
| Fence Solid Retractor 4” x 5” | In distribution | |
| Kelly Retractor 2″ x 5″ | In distribution | |
| Kelly 2″ x 7″ Retractor Aluminum/Radiolucent | In distribution | |
| Straight Segments Medium 6” Sold in Pairs | In distribution | |
| Skin Rake Retractor 4-Prong 3/4″ W x 1/3″ D Titanium/Radiolucent | In distribution | |
| Balfour Retractor 3 3/8″ x 1 1/2″ | In distribution | |
| Horizontal Solid Bar 1” | In distribution | |
| Round Ring Medium 10.5” | In distribution | |
| Yu-Holtgrewe Malleable Retractor 2.5″ W x 7” D | In distribution | |
| Malleable Retractor 2″ x 10″ with Protective Edge | In distribution | |
| Gelpi Hook Point Retractor | In distribution | |
| Malleable Retractor 4″ x 8″ with Protective Edge | In distribution | |
| Wylie Vein Retractor 1” x 5” Aluminum/Radiolucent | In distribution | |
| Kelly Retractor 1″ x 6″ | In distribution | |
| Oval Ring Large 12” x 18.5” Titanium/Radiolucent | In distribution | |
| Malleable Retractor 4″ x 12″ with Protective Edge | In distribution | |
| Table Post 12” (30 cm) | In distribution | |
| Kelly Retractor 1″ x 1 1/2″ | In distribution | |
| Balfour Retractor 3 3/8″ x 4″ | In distribution | |
| Balfour Retractor 2 3/4″ x 2″ | In distribution | |
| Meyerding Retractor Large 2” x 3-3/4” with Teeth | In distribution | |
| Malleable Retractor 1 1/2″ x 6″ with Protective Edge | In distribution | |
| Kelly 2″ x 5″ Retractor Aluminum/Radiolucent | In distribution | |
| Straight Segments Small 4” Sold in Pairs | In distribution | |
| Balfour Swivel Retractor 3 1/4″ x 2 3/4″ Aluminum/Radiolucent | In distribution | |
| Kelly Retractor 1″ x 3″ | In distribution | |
| Kelly 2″ x 2″ Retractor Aluminum/Radiolucent | In distribution | |
| Hook Scoville Retractor Small 2” Titanium/Radiolucent | In distribution | |
| St. Mark’s Retractor 9″ with Lip | In distribution | |
| Table Post 18” (45 cm) | In distribution | |
| Oval Ring Small 8” x 12.5” Titanium/Radiolucent | In distribution | |
| Kelly 2″ x 8″ Retractor Aluminum/Radiolucent | In distribution | |
| Meyerding Retractor Large 2” x 3 3/4” NO Teeth | In distribution | |
| Twist Ratchet Adapter | In distribution | |
| Round Ring Large 12.5” | In distribution | |
| Oval Ring Medium 10.5” x 14.5” Titanium/Radiolucent | In distribution | |
| Kelly Retractor 2″ x 6″ Titanium/Radiolucent | In distribution | |
| Kelly Retractor 2″ x 3″ Titanium/Radiolucent | In distribution | |
| Segmented Oval Ring Small 8.5″ x 14″ | In distribution | |
| Kelly Retractor 1″ x 2 1/2″ | In distribution | |
| Wylie Vein Retractor 1” x 7” | In distribution | |
| Deaver Retractor 3” x 10” | In distribution | |
| Wylie Vein Retractor 1” x 5” | In distribution | |
| Kelly Retractor 2″ x 4″ | In distribution | |
| St. Mark’s Retractor 7″ with Lip | In distribution | |
| Kelly Retractor 2″ x 5″ Titanium/Radiolucent | In distribution | |
| Wylie Vein Retractor 1” x 8” Aluminum/Radiolucent | In distribution | |
| Malleable Retractor 2″ x 6″ with Protective Edge | In distribution | |
| Kelly Retractor 2″ x 2 1/2″ | In distribution | |
| Deaver Retractor 1” x 3 1/2” | In distribution | |
| IMA Ratchet | In distribution | |
| Goulet Retractor Small 1 1/4″ x 1 1/4” | In distribution | |
| Baby Harrington Retractor 1/2” x 2 1/2” x 2” | In distribution | |
| Skin Rake Retractor 4-Prong 3/4″ W x 1/3″ D | In distribution | |
| Harrington Retractor 2 1/2″ x 8″ x 3 1/2″ | In distribution | |
| Wylie Vein Retractor 1” x 8” | In distribution | |
| Kelly 2″ x 4″ Retractor Aluminum/Radiolucent | In distribution | |
| Meyerding Retractor Medium with Teeth 1” x 3 1/3” Titanium/Radiolucent | In distribution | |
| Rake 3-Prong with Rotation 5/8” x 7/8” | In distribution | |
| Kelly Retractor 1″ x 5″ | In distribution | |
| Kelly Retractor 2″ x 2″ | In distribution | |
| Round Ring Small 8.5” | In distribution | |
| Horizontal Flex Bar 1” | In distribution | |
| St. Mark’s Retractor 8″ with Lip | In distribution | |
| Segmented Round Ring Large 12.5” Diameter | In distribution | |
| Malleable Retractor 6″ x 9″ with Protective Edge | In distribution | |
| Kelly Retractor 1″ x 4″ | In distribution | |
| Kelly 1″ x 5″ Retractor Aluminum/Radiolucent | In distribution | |
| Balfour Retractor 3″ x 2″ | In distribution | |
| Malleable Retractor 3″ x 9″ with Protective Edge | In distribution | |
| Meyerding Retractor Small 2/3” x 2 1/3” with Teeth | In distribution | |
| Kelly Retractor 2.5″ x 8″ | In distribution | |
| Balfour Retractor 3 1/2″ x 2 3/4″ | In distribution | |
| Harrington Retractor 2 1/2″ x 5 5/8″ x 3 1/2″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
Showing 12 of 2,238. All products under Retractor
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K942002 | 1994-05-17 |
| K792145 | 1979-12-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.