14 results · 25ms · Sources: EU EUDAMED, 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