13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
Oticon
FDA UDI
Oticon A/S·05707131340047·SIYA 2, KIT 312 2.4G NFM 90 L C001
PRO-PICC
FDA 510(k)
FDA Class 2
·General Hospital
SMDIA-1000
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
M2A-38 CUP NON FLARED SZ 54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 22, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 4, 2011
DLT TS CER HD 12/14 32MM +1
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HTQ·October 4, 2021
SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·July 18, 2024
ALTRX LIP LNR 32IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 4, 2021
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 18, 2024
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017