19 results · 20ms · Sources: EU EUDAMED, US FDA

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PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

Polystar Selection EDITION

FDA UDI
Merz Dental GmbH·D7091982090·posteriors; shade C3; size L; upper jaw

9131 DEFIBRILLATION ELECTRODES

FDA 510(k)
FDA Class 3 ·Cardiovascular

AposTherapy System

FDA 510(k)
FDA Class 1 ·Physical Medicine

TSRH SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 31, 2015

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·November 23, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 16, 2017

ENDOPATH ETS

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY·Product code KOG·April 20, 1998

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·February 8, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 5, 2014

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·August 21, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 4, 2012

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024