15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
KODAK DIRECTVIEW DR SYSTEM DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDRAD MANUAL SYRINGE LOADER
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN COPELAND SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·April 14, 2017
COPELAND SH HUM SZ4 STND PLUS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·June 8, 2016
UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·October 21, 2016
UNKNOWN COPELAND RESURFACING SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·May 16, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 2, 2019
UNKNOWN COPELAND SHOULDER GLENOID COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·July 5, 2017
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012
ASR ACETABULAR IMPLANT 64
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 10, 2013
FOOTED ATTACHMENT 2.4MM LEGEND, AF02 (B-1)
FDA Adverse Event
Malfunction
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·May 21, 2008
EXETER CONTEMPORARY. CUP
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code JDI·April 4, 2011
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012