Unitedstates Surgical
Country not established
- Devices
- 2
- FDA recalls
- 23
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- 510(k) 510(k)
Modification To Spiral Radius 90-D Sst System Ref K021825
510(k) 510(k)
FDA recalls
2006
- 22 May 2006 Z-1148-06 Unclassified (pre-2012) Terminated The 9F device may contain a 10 F sheath instead of the 9F
Full distribution text
- 22 May 2006 Z-1149-06 Unclassified (pre-2012) Terminated The 9F device may contain a 10 F sheath instead of the 9F
Full distribution text
- 22 May 2006 Z-1150-06 Unclassified (pre-2012) Terminated The 9F device may contain a 10 F sheath instead of the 9F
Full distribution text
- 22 May 2006 Z-1151-06 Unclassified (pre-2012) Terminated The 9F device may contain a 10 F sheath instead of the 9F
Full distribution text
- 22 May 2006 Z-1152-06 Unclassified (pre-2012) Terminated The 9F device may contain a 10 F sheath instead of the 9F
Full distribution text
- 22 May 2006 Z-1153-06 Unclassified (pre-2012) Terminated The 9F device may contain a 10 F sheath instead of the 9F
Full distribution text
- 22 May 2006 Z-1148-06 Unclassified (pre-2012) Terminated The 9F device may contain a 10 F sheath instead of the 9F
2005
- 30 Jun 2005 Z-1091-05 Unclassified (pre-2012) Terminated The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 30 Jun 2005 Z-1092-05 Unclassified (pre-2012) Terminated The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 30 Jun 2005 Z-1093-05 Unclassified (pre-2012) Terminated The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 30 Jun 2005 Z-1094-05 Unclassified (pre-2012) Terminated The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
Show all 23 recalls
2005
- 30 Jun 2005 Z-1095-05 Unclassified (pre-2012) Terminated The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 30 Jun 2005 Z-1096-05 Unclassified (pre-2012) Terminated The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 30 Jun 2005 Z-1097-05 Unclassified (pre-2012) Terminated The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 30 Jun 2005 Z-1098-05 Unclassified (pre-2012) Terminated The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
2004
- 5 May 2004 Z-0958-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0959-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0960-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0961-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0962-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0963-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0964-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0965-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
- 5 May 2004 Z-0966-04 Unclassified (pre-2012) Terminated Stapler may clamp without the staples being fired into the tissue
Frequently asked questions
How many devices does Unitedstates Surgical have in the registry?
The registry currently lists 2 devices for Unitedstates Surgical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unitedstates Surgical's devices?
Among its 2 most recently registered devices, Unitedstates Surgical has devices listed in FDA 510(k) (2 devices).
What risk classes do Unitedstates Surgical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Unitedstates Surgical's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Unitedstates Surgical?
FDA recall records list 23 recalls initiated by Unitedstates Surgical, the most recent initiated on 2006-05-22. 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 Unitedstates Surgical in the registry?
The most recently registered devices listed for Unitedstates Surgical include SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE and MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM.