Smith & Nephew Inc., Endoscopy Division
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 121
At a glance
Market reach
- United States
- FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Gynecology Sterilization Tray Ref K121904
Regimes: 510(k) Registry: 510(k)Smith & Nephew Kinsa Rc Suture Anchor Ref K070908
Regimes: 510(k) Registry: 510(k)Endobutton Direct Ref K070167
Regimes: 510(k) Registry: 510(k)Endobutton Direct Ref K102982
Regimes: 510(k) Registry: 510(k)Endobutton Continuous Loop (Cl) Ref K081098
Regimes: 510(k) Registry: 510(k)Twinfix Ft Pk Ref K072785
Regimes: 510(k) Registry: 510(k)Bioraptor 2.3 Pk Suture Anchor Ref K071586
Regimes: 510(k) Registry: 510(k)Osteoraptor Suture Anchor Ref K082215
Regimes: 510(k) Registry: 510(k)
FDA recalls
2014
- 2 Jun 2014 Z-2045-2014 Class II Terminated Sterility of device is compromised due to breach in sterile barrier
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- 2 Jun 2014 Z-2046-2014 Class II Terminated Sterility of device is compromised due to breach in sterile barrier
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- 2 Jun 2014 Z-2047-2014 Class II Terminated Sterility of device is compromised due to breach in sterile barrier
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- 2 Jun 2014 Z-2048-2014 Class II Terminated Sterility of device is compromised due to breach in sterile barrier
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- 2 Jun 2014 Z-2049-2014 Class II Terminated Sterility of device is compromised due to breach in sterile barrier
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- 2 Jun 2014 Z-2045-2014 Class II Terminated Sterility of device is compromised due to breach in sterile barrier
2013
- 6 Aug 2013 Z-2215-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2216-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2217-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2218-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2219-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2215-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Show the 25 most recent of 121 recalls
2013
- 6 Aug 2013 Z-2220-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2221-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2222-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2223-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2224-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2225-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2226-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2227-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2228-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2229-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2230-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2231-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2232-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2233-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2234-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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- 6 Aug 2013 Z-2220-2013 Class II Terminated Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Frequently asked questions
How many devices does Smith & Nephew Inc., Endoscopy Division have in the registry?
The registry currently lists 8 devices for Smith & Nephew Inc., Endoscopy Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smith & Nephew Inc., Endoscopy Division's devices?
Among its 8 most recently registered devices, Smith & Nephew Inc., Endoscopy Division has devices listed in FDA 510(k) (8 devices).
What risk classes do Smith & Nephew Inc., Endoscopy Division's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Smith & Nephew Inc., Endoscopy Division's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Smith & Nephew Inc., Endoscopy Division?
FDA recall records list 121 recalls initiated by Smith & Nephew Inc., Endoscopy Division, the most recent initiated on 2 Jun 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Smith & Nephew Inc., Endoscopy Division in the registry?
The most recently registered devices listed for Smith & Nephew Inc., Endoscopy Division include GYNECOLOGY STERILIZATION TRAY, SMITH & NEPHEW KINSA RC SUTURE ANCHOR, ENDOBUTTON DIRECT and ENDOBUTTON CONTINUOUS LOOP (CL).