28 results · 26ms · Sources: EU EUDAMED, US FDA

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MDI DS-DNA TEST

FDA 510(k)
FDA Class 2 ·Immunology

Sledgehammer

FDA UDI
Keystone Industries·H66810004771·HC 25 lb Pwd & 4 Qt Liq Kit, Original

Implant Prosthetics

FDA UDI
Preat Corporation·00842092116494·NobelBiocare™ Tri-Lobe-compatible NP Straight M...

Implant Prosthetics

FDA UDI
Preat Corporation·00842092130957·NobelBiocare™ Tri-Lobe-compatible NP Straight M...

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167700004770·

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167S1700004770·

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 26, 2026

RENEGADE HI-FLO MICROCATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

STERIS AMSCO MILLENNIUM STEAM STERILIZER

FDA 510(k)
FDA Class 2 ·General Hospital

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

FDA Adverse Event
FUTURE DIAGNOSTICS B.V.·Product code CEW·November 1, 2017

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 12, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·January 31, 2011

ZENITH FLEX AAA ENDOVASCULAR GRAFT

FDA Adverse Event
Injury ·COOK INCORPORATED·Product code MIH·February 21, 2008

UNKNOWN HIP ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 20, 2019

UNKNOWN HIP ACETABULAR CUP

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWY·November 26, 2019

UNKNOWN HIP FEMORAL STEM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 26, 2019

UNKNOWN HIP FEMORAL STEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 20, 2019

UNKNOWN HIP FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 20, 2019

BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012