11 results
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27ms
·
Sources: EU EUDAMED, US FDA
GOOSEN SELF-LUBRICATING CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Intrisound Tuned Lumen® 155 Hearing Aids
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
FDA 510(k)
FDA Class 2
·Radiology
LATERAL STRAIGHT STEM 15.0 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·March 28, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 22, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 8, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 9, 2014
SULOX-HD 32 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·April 23, 2019
SULOX, HEAD, M¸ 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·August 3, 2018
SULOX-HEAD 28 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·April 4, 2019
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024