15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Triglycerides
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Leg Bag
FDA UDI
C. R. Bard, Inc.·00801741050879·Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Va...
HHM
FDA UDI
Oticon A/S·05707131280831·H160V2, BTE 13 WL 100 TC HHM
CHARLOTTE SNAP-OFF SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
SMALL BATTERY DRIVE 12V BATTERY
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·December 17, 2015
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 6, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 6, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019