10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
LEARN MODE WATERPROOF PENDANT PANIC BUTTON
FDA 510(k)
FDA Class 2
·Physical Medicine
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E89649402230·Crown trial forceps US-Model
17cm
N/A
FDA UDI
Tyber Medical, LLC·M695M9402230·
POLYVAC INSTRUMENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
FMT Disposable and Autoclavable Temperature Probes
FDA 510(k)
FDA Class 2
·General Hospital
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·December 9, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017