16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IDODENTINE DISC, IDODENTINE BLOCK
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II
Leg Bag
FDA UDI
C. R. Bard, Inc.·00801741080661·Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Va...
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239531·
Oticon
FDA UDI
Oticon A/S·05707131289193·H11V2 TI, MINIRITE 312 WL TC
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
FDA 510(k)
FDA Class 2
·General Hospital
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
FDA 510(k)
FDA Class 2
·Hematology
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 19, 2026
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 16, 2017
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 6, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 8, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
OPTITORQUE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·Product code DQO·January 20, 2021
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024