15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDLEY GOLD
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257141571·20-30 MFW VITALITY CALF CT CHARC V
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017743·K-Wire, Double Ended, Trocar Point, Diameter Si...
AGILITY
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295035787·AGILITY LP TOTAL ANKLE SYSTEM +1 POLY INSERT SI...
AGILITY
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295035770·AGILITY LP TOTAL ANKLE SYSTEM POLY INSERT SIZE 5
AGILITY
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295035794·AGILITY LP TOTAL ANKLE SYSTEM POLY INSERT MISMA...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197054980·McQuigg-Mixter Hemostatic Forceps
220mm,...
AMEDA PLATINUM BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
FDA 510(k)
FDA Class 2
·Immunology
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code DTS·January 13, 2014
RESTORE EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 31, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 16, 2011
BIOLOX DELTA CER LNR 36MM E
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LZO·March 28, 2025
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU 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
GMK-HINGE FEMORAL COMPONENT SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·November 17, 2017