17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Bioseal Inc.
FDA UDI
BIOSEAL·00630094689012·Vaginal Speculum Clear w/ Light Wrapped
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158210790·SCISSOR LISTER BANDAGE 8"
PROCARE
FDA UDI
DJO, LLC·00888912037266·LIMB RESTR,BUCKLE,UNIV,10PR/PK
General
FDA UDI
Seaspine Orthopedics Corporation·10889981143282·Graft Delivery Instrument Tray Case - Lid
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
FDA 510(k)
FDA Class 2
·Cardiovascular
VINNO 8, VINNO 6, VINNO 5
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER® CTAD BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 4, 2018
BD VACUTAINER® CTAD BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 31, 2018
BD VACUTAINER® CTAD BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 3, 2018
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 5, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 7, 2014
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 9, 2021
ZIMMON PANCREATIC STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 16, 2020
SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MMK·March 12, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020