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