Elmed Incorporated

Balfour Abdominal Retractor- USA Improved Version with interchangeable Blades, With 9” operating spread- complete with Central Blade 50 x 75mm and (2) Sets Fenestrated Side , Blades…

Registry build 21.09.26

Balfour Abdominal Retractor- USA Improved Version with interchangeable Blades, With 9” operating spread- complete with Central Blade 50 x 75mm and (2) Sets Fenestrated Side , Blades → Qty.(2) 2-1/2” deep and Qty. (2) 3-1/2” deep. Autoclavable Medical Grade Stainless Steel.

34manufacturers in China registered for this device type
409catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code GAD
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

Regulatory record for Elmed Incorporated
Listed by Elmed, Inc., United States
FDA product code GAD
Device type Retractor
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2025-03-17
Record revised 2025-08-15 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2026-05-15

Catalogue Numbers

Catalogue numbers for Elmed Incorporated
Catalogue number Size Status
ST241506 In distribution
AMP-1640C-TS In distribution
23-869054 In distribution
SM24-0519-02 In distribution
18-MCLT10 In distribution
ST155920E In distribution
18-32025 In distribution
24-8999-06 In distribution
24110-702 In distribution
ST1980214 In distribution
52550-14 In distribution
STESM150621AC08I In distribution
19681-21M In distribution
T9910 FS-AN-TM In distribution
ST5240001 In distribution
18-2951-76 In distribution
ST152604E In distribution
B9923F-AN In distribution
ST321624I In distribution
ST5243003 In distribution
15-ASI226F In distribution
ST241501 In distribution
23-213110FLT In distribution
ST153701 In distribution
F9923 FS In distribution
52450-03 In distribution
23-509575 In distribution
ST15842203 In distribution
STT9932FSAN In distribution
STE234696FRAME In distribution
ST153501E In distribution
ST1912514 In distribution
ST322502I In distribution
23-584101 In distribution
9880 RO In distribution
STE9882FSRAS In distribution
F9932 FS In distribution
23-1902-N In distribution
23-0829-08 In distribution
ST5243005 In distribution
ST322500E In distribution
T9850FS In distribution
ST5242003H In distribution
ST15360 In distribution
18-504568 In distribution
ST241504 In distribution
18-3148 In distribution
ST5240902 In distribution
19150-04 In distribution
15-34-02LSI In distribution
23-14401020 In distribution
F9933 FS In distribution
ST322922I In distribution
ST5241203 In distribution
37322-26FS In distribution
SM-T9931FS-AN-T In distribution
ST153342 In distribution
23-629000075 In distribution
ST3601810I In distribution
23-869051 In distribution
STET9923FSANT In distribution
15088-08-26 In distribution
ST4108520 In distribution
15-26-06 In distribution
15-246104 In distribution
ST5240901 In distribution
ST3212413I In distribution
STS5017751 In distribution
SM01-1124TT-02 In distribution
ST5243005H In distribution
ST232825 In distribution
38-881190 In distribution
ST152604I In distribution
STE184017 In distribution
ST5243000 In distribution
ST5243002H In distribution
STE3212213E In distribution
ST5242000H In distribution
STE152602I In distribution
STT9923FSAN In distribution
23-MH6E In distribution
T9920R FS-AN-T In distribution
23-762102 In distribution
B9923 F-AD-C In distribution
37-61029 In distribution
ST379670 In distribution
ST5243001H In distribution
ST15TLSRSR In distribution
ST5240903 In distribution
ST5241200 In distribution
B9923 FS-AN In distribution
69127-02 In distribution
ST151616I In distribution
ST5242006 In distribution
B9942 FS-AN In distribution
ST3212413E In distribution
57246-161 In distribution
18-MCLT11 In distribution
STSM150621AC In distribution
ST234552 In distribution
ST3601810E In distribution
ST4107921 In distribution
ST151616E In distribution
15-246105 In distribution
52736-LTR9-H In distribution
STESM150526JC08I In distribution
STT9931FSAN In distribution
15-TLSRSR-A In distribution
STE3451802 In distribution
9841F-T In distribution
15-59-25-I In distribution
15-246105 In distribution
23-7450-02 In distribution
ST158121 In distribution
ST152602E In distribution
STT9931FSST In distribution
23-4535 In distribution
18-10272 In distribution
23-3170104 In distribution
23-6595-30 In distribution
ST5511717 In distribution
15-VM5385 In distribution
15-01-85EN In distribution
15-972F In distribution
ST153900E In distribution
15-CCR00665-3 In distribution
ST5242001H In distribution
ST1967016 In distribution
9885 FS-RAS In distribution
STE322924I In distribution
B9911 FAD-C In distribution
15088-00-23 In distribution
ST241503 In distribution
ST23TKBAR In distribution
ST23584101 In distribution
ST379675 In distribution
ST5242005 In distribution
18-5001-YH8 In distribution
STT9923FSST In distribution
STE23469605 In distribution
ST322922E In distribution
ST6915015 In distribution
19150-01 In distribution
ST5243001 In distribution
23-1225JG In distribution
ST322924E In distribution
ST151617I In distribution
18-634OL In distribution
T9943 F-AN In distribution
15-246114 In distribution
STESM150621AC04I In distribution
24-8999-04 In distribution
24-8999-01 In distribution
ST152601E In distribution
T9941 FS-ST In distribution
ST321604 In distribution
STE153503E In distribution
T9910R FS-AN-T In distribution
ST5243301 In distribution
ST155920I In distribution
9878 FT In distribution
15088-00-NR In distribution
STS5017750 In distribution
38-881086 In distribution
52460-03-H In distribution
15089-1 In distribution
STT9911FST In distribution
T9942 FS-AN In distribution
ST153700E In distribution
15-CCR00665-1 In distribution
38-GGMH08 In distribution
ST155925E In distribution
T-I9911 FS-T In distribution
T9932 FS-AN In distribution
ST5243002 In distribution
23-00780700401 In distribution
23-80400099 In distribution
ST5241201 In distribution
ST151514E In distribution
ST151720E In distribution
STT9923FADS In distribution
SM19784-99RC In distribution
01-105555HD In distribution
STE9878FSRAS In distribution
52470-03 In distribution
STT9943FADS In distribution
ST5240000 In distribution
23-59004025 In distribution
23-6210-02 In distribution
STE371130 In distribution
ST361165 In distribution
23-780406 In distribution
ST155906E In distribution
STE193191 In distribution
ST5246005H In distribution
ST3601816E In distribution
42-5301 In distribution
ST5242002 In distribution
ST5243000H In distribution
ST5240905 In distribution
STE2313519 In distribution
15-4568 In distribution
ST152601I In distribution
23-0829-06 In distribution
ST153900I In distribution
ST152603I In distribution
57236-25 In distribution
23-6195-00-003 In distribution
STE3412108 In distribution
ST3601812I In distribution
15088-00-22 In distribution
15-4569 In distribution
15-246113 In distribution
STESM150199SJ In distribution
T9852FS In distribution
15-246115 In distribution
ST153700I In distribution
ST5243003H In distribution
15-425-28 In distribution
19784-99 In distribution
ST155910I In distribution
T9921FS-AN-TM In distribution
24-8999-03 In distribution
ST241502 In distribution
15-246174 In distribution
ST5242002H In distribution
18-631 In distribution
ST5243004H In distribution
ST3601814E In distribution
ST153535E In distribution
52460-02-H In distribution
38-GMHM08 In distribution
STE322500E In distribution
ST152602I In distribution
19670-16-IT In distribution
STE23469607 In distribution
15-32-2050 In distribution
24-EX522016 In distribution
15-4559 In distribution
15-4560 In distribution
STE23469604 In distribution
STE1508916 In distribution
ST1508915 In distribution
ST155925I In distribution
ST5246004H In distribution
STT9920FSANT In distribution
ST151514I In distribution
15-11702 In distribution
T9910FS-AN-T-R In distribution
T9920 FS-ST In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer