39 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EARPROBE
FDA 510(k)
FDA Class 2
·Neurology
Criterion OxiCheck
FDA UDI
Respironics Novametrix, LLC·00884838083189·
Eclipse Vent Diffuser Kit
FDA UDI
BLEEP, LLC·00850003157177·
NITANIUM® SUPER ELASTIC ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707059743·.016 X .016 LOWER NITANIUM® SUPER ELASTIC PRO F...
Monoblock Tibial Trial PS Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042646·
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494462153·Bone Chisel Awl
Plastic Handle
D 3.0mm, WL 310mm
RANDOX PREALBUMIN
FDA 510(k)
FDA Class 1
·Immunology
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code IOR·May 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 17, 2011
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DRC·October 20, 2021
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·January 8, 2014
NOVOSYN QUICK UNDY 2/0(3)70CM DSMP24MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·April 23, 2021
NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021
NOVOSYN QUICK UNDY 3/0(2)70CM DS19(M)DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 29, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021