7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LEGIONELLA IFA KIT I
FDA 510(k)
FDA Class 2
·Microbiology
VIEWPOINT TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
WHIP MIX PREPPIES PLUS
FDA 510(k)
FDA Class 1
·Dental
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 9, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014
SIZE 2.0 STRYKER DRILL BIT.
FDA Adverse Event
STRYKER·Product code HWE·August 25, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024