16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAGEWRITER TC 20, 30, 50, 70
FDA 510(k)
FDA Class 2
·Cardiovascular
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
BIO-MODULAR / BI-POLAR SHOULDER
FDA UDI
Biomet Orthopedics, LLC·00880304212398·
Oticon
FDA UDI
Oticon A/S·05707131233851·GET, BTE 13 DBL
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131449·FOR MEN CASUAL 30-40 MM HG KNEE HIGH CLOSED TOE...
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·PHILIPS NORTH AMERICA LLC·Product code BZD·December 2, 2022
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 9, 2013
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 11, 2008
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