Atraumata
COOLEY ATRAUMATA Anastomosis Clamp, curved, 20 °, 6 3/4", (170 mm), pediatric pattern, satinsky-shaped, toothing COOLEY, (72 mm), width: 17 mm, non-sterile, reusable
24manufacturers in China registered for this device type
196catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (5), Shanghai (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Linhai Deyi Plastic Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 15 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for Clamp
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HXD |
| Device type | Clamp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-21 |
| Record revised | 2022-06-10 (version 3) |
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 |
| Distribution end date | 2021-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FB592R | In distribution | |
| FC326T | In distribution | |
| FB702R | In distribution | |
| FB508R | In distribution | |
| FB469R | In distribution | |
| FB480R | In distribution | |
| FB670R | In distribution | |
| FB382R | In distribution | |
| FB732R | In distribution | |
| FB467R | In distribution | |
| FB477R | In distribution | |
| FB723R | In distribution | |
| FB567R | In distribution | |
| FB735R | In distribution | |
| FB513R | In distribution | |
| FC325T | In distribution | |
| FB424R | In distribution | |
| FC342T | In distribution | |
| FC337T | In distribution | |
| FC330T | In distribution | |
| MB752R | In distribution | |
| FC340T | In distribution | |
| FB453R | In distribution | |
| FC341T | In distribution | |
| FB454R | In distribution | |
| FB504R | In distribution | |
| FB540R | In distribution | |
| FB427R | In distribution | |
| FB617R | In distribution | |
| FB775R | In distribution | |
| FB722R | In distribution | |
| FB518R | In distribution | |
| FB431R | In distribution | |
| FB573R | In distribution | |
| FC336T | In distribution | |
| FB574R | In distribution | |
| FB547R | In distribution | |
| FB776R | In distribution | |
| FB714R | In distribution | |
| FB549R | In distribution | |
| FB421R | In distribution | |
| FB715R | In distribution | |
| FB581R | In distribution | |
| FB706R | In distribution | |
| FB619R | In distribution | |
| FB764R | In distribution | |
| FB512R | In distribution | |
| FB712R | In distribution | |
| FC339T | In distribution | |
| FB420R | In distribution | |
| FB590R | In distribution | |
| FC332T | In distribution | |
| FC333T | In distribution | |
| FB434R | In distribution | |
| FB466R | In distribution | |
| FB710R | In distribution | |
| FB515R | In distribution | |
| FC335T | In distribution | |
| FB558R | In distribution | |
| FB765R | In distribution | |
| FB704R | In distribution | |
| FB737R | In distribution | |
| FB705R | In distribution | |
| FB755R | In distribution | |
| FB352R | In distribution | |
| FC322T | In distribution | |
| FB511R | In distribution | |
| FB546R | In distribution | |
| FB519R | In distribution | |
| FB520R | In distribution | |
| FB717R | In distribution | |
| FB727R | In distribution | |
| FB543R | In distribution | |
| FB470R | In distribution | |
| FB461R | In distribution | |
| FB500R | In distribution | |
| FB700R | In distribution | |
| FB778R | In distribution | |
| FB569R | In distribution | |
| FC327T | In distribution | |
| FB456R | In distribution | |
| FB491R | In distribution | |
| FB488R | In distribution | |
| FB436R | In distribution | |
| FB578R | In distribution | |
| FB528R | In distribution | |
| FB730R | In distribution | |
| FB464R | In distribution | |
| FB426R | In distribution | |
| FB542R | In distribution | |
| FB494R | In distribution | |
| FB432R | In distribution | |
| FB525R | In distribution | |
| FC321T | In distribution | |
| FB703R | In distribution | |
| FB473R | In distribution | |
| FB591R | In distribution | |
| FB725R | In distribution | |
| FC329T | In distribution | |
| FB507R | In distribution | |
| FB707R | In distribution | |
| FB457R | In distribution | |
| FB468R | In distribution | |
| EA221R | In distribution | |
| FB383R | In distribution | |
| FB738R | In distribution | |
| FB731R | In distribution | |
| FB582R | In distribution | |
| FB460R | In distribution | |
| FB795R | In distribution | |
| FB780R | In distribution | |
| FB493R | In distribution | |
| FB517R | In distribution | |
| FB455R | In distribution | |
| FC324T | In distribution | |
| FB476R | In distribution | |
| FB729R | In distribution | |
| FB576R | In distribution | |
| FB568R | In distribution | |
| FB713R | In distribution | |
| FB490R | In distribution | |
| FB425R | In distribution | |
| FB433R | In distribution | |
| FB618R | In distribution | |
| FC331T | In distribution | |
| FB384R | In distribution | |
| FB510R | In distribution | |
| FB489R | In distribution | |
| FB481R | In distribution | |
| FB743R | In distribution | |
| FC323T | In distribution | |
| FB550R | In distribution | |
| FB478R | In distribution | |
| FB754R | In distribution | |
| FB544R | In distribution | |
| FB475R | In distribution | |
| FB766R | In distribution | |
| FB502R | In distribution | |
| FB385R | In distribution | |
| FB777R | In distribution | |
| FB471R | In distribution | |
| FB459R | In distribution | |
| FB726R | In distribution | |
| FB669R | In distribution | |
| FB724R | In distribution | |
| FB358R | In distribution | |
| FB423R | In distribution | |
| FB721R | In distribution | |
| FC334T | In distribution | |
| FB557R | In distribution | |
| FB767R | In distribution | |
| FB452R | In distribution | |
| FB773R | In distribution | |
| EA220R | In distribution | |
| FB708R | In distribution | |
| FB503R | In distribution | |
| FB353R | In distribution | |
| FB357R | In distribution | |
| FB501R | In distribution | |
| FB465R | In distribution | |
| FB541R | In distribution | |
| FB463R | In distribution | |
| FB548R | In distribution | |
| FB458R | In distribution | |
| FB492R | In distribution | |
| FB495R | In distribution | |
| FB779R | In distribution | |
| FC343T | In distribution | |
| MB613R | In distribution | |
| FB718R | In distribution | |
| FC320T | In distribution | |
| FB509R | In distribution | |
| FB435R | In distribution | |
| FB736R | In distribution | |
| FB462R | In distribution | |
| FB506R | In distribution | |
| FB422R | In distribution | |
| FB701R | In distribution | |
| FB359R | In distribution | |
| FB711R | In distribution | |
| FC328T | In distribution | |
| FB516R | In distribution | |
| FB756R | In distribution | |
| FB719R | In distribution | |
| FB437R | In distribution | |
| FC338T | In distribution | |
| FB734R | In distribution | |
| FB472R | In distribution | |
| FB593R | In distribution | |
| FB482R | In distribution | |
| FB641R | Withdrawn | |
| FB642R | Withdrawn | |
| FB649R | Withdrawn | |
| FB647R | Withdrawn | |
| FB644R | Withdrawn | |
| FB640R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Innomed, Inc. | Innomed, Inc. | 166 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 136 |
| Orthomed | Ortho-MED, Inc. | 115 |
| Aesculap | Aesculap AG | 110 |
| Surtex | Surtex Instruments Ltd | 93 |
| Lazic | Peter Lazic Gmbh | 91 |
| Clamp | Black & Black Surgical, Inc. | 81 |
| Ambler Surgical | Ambler Surgical, LLC | 77 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 60 |
| Pilling | Teleflex Medical LLC | 55 |
| American Medicals | American Medicals | 49 |
| Marina Medical | Marina Medical Instruments, Inc. | 44 |
Showing 12 of 426. All products under Clamp
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-01-31 | Class II | Use error | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | 1,147 forceps |
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.