15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wi-3 HAL-RAR System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE
CT/MR M.A.C. Interstitial GYN Template, 18G
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024268·
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020256·Posterior Stabilized Tibial Insert
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DDRCOMBI TRAUMA
FDA 510(k)
FDA Class 2
·Radiology
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
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 6, 2013
ACT III SENSOR
FDA Adverse Event
Malfunction
·LIFEWATCH SERVICES, INC.·Product code DSI·June 22, 2011
BD MICROLANCE¿ 3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·October 30, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017