30 results · 27ms · Sources: EU EUDAMED, US FDA

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ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST

FDA 510(k)
FDA Class 2 ·Immunology

BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

FDA Adverse Event
Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

Sledgehammer

FDA UDI
Keystone Industries·H66810004891·SC 25 lb Pwd & 4 Qt Liq Kit, Original

Implant Prosthetics

FDA UDI
Preat Corporation·00842092116975·NobelBiocare™ Tri-Lobe-compatible NP Multi-Unit...

Affiniti

FDA UDI
TORNIER, INC.·00846832023608·TUBEROSITY REAMER

Implant Prosthetics

FDA UDI
Preat Corporation·00842092133040·NobelBiocare™ Tri-Lobe-compatible NP Multi-Unit...

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167700004890·

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167S1700004890·

PQ1

FDA 510(k)
FDA Class 2 ·Dental

SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAILS-STER

FDA Adverse Event
Injury ·SYNTHES USA·Product code HSB·September 20, 2013

4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER

FDA Adverse Event
Injury ·SYNTHES USA·Product code HSB·September 20, 2013

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·May 18, 2015

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·March 12, 2013

INRATIO2

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO·Product code GJS·January 31, 2011

PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·February 21, 2008

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·August 27, 2015

5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 11, 2018

OMNIPOD 5 CONTROLLER

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·January 30, 2023

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