9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TorqVue Low Profile Delivery Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Bernafon
FDA UDI
Bernafon AG·05711584059029·SU9 P, VC PS SABE/MSIL SUITE 9
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Neurology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 11, 2013
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 7, 2011
FOX PLUS PTA CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR SWITZERLAND·Product code LIT·September 16, 2008
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·January 25, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024