25 results · 21ms · Sources: EU EUDAMED, US FDA

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GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0380850·T-Handle, Stealth, Quarter Square, Impact

SOMNO STAR & SERIES SLEEP SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

ULTRASOUND SCANNER, TYPE 1101

FDA 510(k)
FDA Class 2 ·Radiology

ORTHO SUMMIT SAMPLE HANDLER

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

TSRH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 2, 2018

SYNCARDIA COMPANION 2 DRIVER

FDA Adverse Event
Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·March 6, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 28, 2011

CONTOUR TEST STRIPS (50)

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 18, 2008

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

TSRH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

TSRH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 25, 2011

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016