16 results
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20ms
·
Sources: EU EUDAMED, US FDA
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
Amara View
FDA UDI
Respironics, Inc.·00606959009288·Amara View Mask with Headgear, FitPack
Phonak
FDA UDI
Phonak AG·07612847818514·Phonak Ambra microP (palladium/black)
PICCOLO CHLORIDE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NITRILE EXAM GLOVE, POWDER FREE, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
BDRV CANN SCW SS P/T DIA4.5X60MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017
VIVACIT-E DM BEARING 28X44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 28, 2026
G7 DUAL MOBILITY LINER 44MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 28, 2026
BDRV CANN SCW SS P/T DIA4.5X52MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·April 19, 2011
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 2, 2013
MICROFX OCD UNIVERSAL DRILL
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code HTO·September 15, 2014
Philips Respironics Amara View Minimal Contact Full-Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
BD SYRINGE 3ML HEPARIN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NZW·September 9, 2019
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024