9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045784·Paddle Shaver, 6mm
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VICTORCH MEDITEK'S HCG TEST CARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2A-MAGNUM RECAP CUP 54ODX48ID
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 24, 2019
HOT PAK LG 6X9
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code IMD·May 15, 2013
ETHIBOND EXCEL POLYESTER SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·September 24, 2014
UNKNOWN DEPUY ASR HIP (LEFT SIDE)
FDA Adverse Event
Other
·DEPUY INTERNATIONAL, LTD·Product code KWA·May 11, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021