11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
ReLine
FDA UDI
Nuvasive, Inc.·00195377073440·RELINE C CoCr Rod, 3.5x350mm Straight
N/A
FDA UDI
Tyber Medical, LLC·M695M9453500·
Guided Reamer
FDA UDI
BICON, LLC·00813110027849·4.5 x 6.0mm Guided Reamer
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HYDROXYAPATITE INFINITY TROCHANTERIC MODULE
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 7, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·December 27, 2010
5.5MM TOMCAT CUTTER, FORMULA (5BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code HRX·December 27, 2012
UNKNOWN
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019