17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EndoLIF On-Cage
FDA 510(k)
FDA Class 2
·Orthopedic
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095620277·Pipette tip, 1-200uL, yellow Eppendorf style
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575304400·Surgical mallet - Endo Model Rotational and Hin...
Statcorp Medical
FDA UDI
Statcorp Medical·10841522104497·BP CUFF,TL SOFT,1T,ADULT,26-35CM,EA
Trulink
FDA UDI
Statcorp Medical·10841522123405·BP CUFF,TL SOFT,1T,ADULT,26-35CM,5/BG
HEARTWAY POWER MOBILITY SCOOTER, S11
FDA 510(k)
FDA Class 2
·Physical Medicine
POLY-CHEM 90 TOTAL BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 21, 2013
ACCU-CHEK COMFORT CURVE
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS CORP.·Product code CGA·September 23, 2004
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
STANDARD INSERT
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWA·June 30, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
COBAS 8000 COBAS ISE MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·October 2, 2012
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026