35 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIGMA Sterilization Pouch and Roll
FDA 510(k)
FDA Class 2
·General Hospital
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197085366·Titan RC Ryder Needle Holder, delicate
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197385725·Titan TC Ryder Needle Holder, delicate
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197085359·Titan TC Ryder Needle Holder, delicate
straig...
EARPROBE
FDA 510(k)
FDA Class 2
·Neurology
MODELS TENS 7000, EMS 7500 AND TWIN STIM
FDA 510(k)
FDA Class 2
·Physical Medicine
ETS LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 17, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·June 20, 2013
PUMP IN STYLE ADVANCED
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·May 5, 2011
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
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 4/0(1,5)45CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 3, 2021
NOVOSYN QUICK UNDY 3/0(2)70CM HR17(M)DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·November 17, 2020
NOVOSYN QUICK UNDY 3/0(2)45CM HS23(M)DDP
FDA Adverse Event
Injury
·B. BRAUN SURGICAL, S.A.·Product code GAM·July 13, 2020