14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pulse* Spray Infusion System, Uni*Fuse Infusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221046109·Unitek(TM) Molar Band General Purpose Wide Hard...
PRUITT CAROTID KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
FDA 510(k)
FDA Class 2
·Hematology
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 4, 2018
DEPTH ELECTRODE
FDA Adverse Event
Malfunction
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021
SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
FDA Adverse Event
Injury
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019
PULSE GENERATOR, PERMANENT, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC INC.·Product code NVZ·October 10, 2014
M2A-MAGNUM 52-60MM TPR INS STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2013
PFC SIGMARP CV TB/IN S3 10.0
FDA Adverse Event
Injury
·DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS·Product code NJL·July 8, 2011
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014