26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123201075·TC CASTRO NH 7-1/4 SERR
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
FDA 510(k)
FDA Class 2
·Immunology
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2015
130° RADIOLUCENT TARGETING ARM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·October 3, 2025
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·April 17, 2025
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·November 5, 2008
ROTALINK (TM) PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MCX·August 24, 2011
ENDOPATH** XCEL* BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 11, 2013
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·December 23, 2025
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·August 9, 2016
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·November 13, 2017
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·August 9, 2016
IGS
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION INC·Product code HAW·January 31, 2025
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code PHX·August 7, 2025
SURETRAK II SMALL PASSIVE FIGHTER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code MAX·February 3, 2025
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 31, 2025
IGS
FDA Adverse Event
Malfunction
·MEDTRONIC INC·Product code HAW·February 3, 2025
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020