17 results · 21ms · Sources: EU EUDAMED, 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