14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Incompass Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813010426·NITI LEGACY MT CM F3 25MM
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197152648·Adaptor for Fibreoptic light guide
Type W...
Xm Uni Driver
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215072537·
devemed
FDA UDI
devemed GmbH·04061644022359·Granulate Plugger "Jovanovic" # 4
3.0 mm / 3.0 ...
Easy@Home blood glucose monitoring system
FDA UDI
HMD BIOMEDICAL INC.·00810038634746·Easy@Home blood glucose monitoring system
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA 510(k)
FDA Class 2
·Radiology
TRIAGE TOX DRUG SCREEN CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Reicodent
FDA UDI
devemed GmbH·04061644037254·Granulate Plugger "Jovanovic" # 4
3.0 mm / 3.0 ...
PINNACLE 100 ACET CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 30, 2017
ENDO GIA ROTICULATOR 60-3.5 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL A·Product code GDW·September 9, 2011
JOSTENT GRAFTMASTER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·November 14, 2008
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013