11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Aero Chrome* Select Breathable Performance Surgical Gowns
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254350·
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575416981·Proximal Tibial Spacer,incl. 2 countersunk scre...
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575417018·Proximal Tibial Spacer,incl. 2 countersunk scre...
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575416950·Proximal Tibial Spacer,incl. 2 countersunk scre...
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
ASPHERE M SPEC 12/14 36 +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·June 11, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·July 15, 2011
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019