33 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIVEWIRE ELECTOPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ILIZAROV
FDA UDI
Smith & Nephew, Inc.·03596010031761·SLOTTED WASHER - SMALL BONE FIXATOR
Tasso Mini
FDA UDI
Tasso Inc.·00850038691134·
neria™ detach
FDA UDI
Unomedical A/S·05705244000995·Single use infusion set for subcutaneous infusi...
LOCKING BONE SCREW MODEL HCQ04, HCZ04
FDA 510(k)
FDA Class 2
·Orthopedic
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOHELP SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 27, 2024
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 27, 2024
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 5, 2024
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 2, 2024
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS INC.·Product code DYB·November 15, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Malfunction
·ARSTASIS, INC.·Product code DYB·November 19, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS, INC.·Product code DYB·November 22, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS, INC.·Product code DYB·November 1, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 9, 2013
AXERA 2 ACCESS SYSTEM
FDA Adverse Event
Malfunction
·ARSTASIS INC.·Product code DYB·August 28, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025