17 results
·
33ms
·
Sources: EU EUDAMED, US FDA
OSMOMETER MODEL 2400
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756394260·BIOPSY PACK
CANDELA SPTL-1E PULSED DYE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENGAGE/ENGAGE TR INTRODUCERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOPATH XCEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·November 30, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 11, 2013
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
PDS II POLYDIOXANONE SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 12, 2018
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 12, 2018
ETHILON NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·April 12, 2018
PDS II POLYDIOXANONE SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 5, 2018
ETHILON NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·April 12, 2018
ETHILON NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·April 5, 2018
PDS II POLYDIOXANONE SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 12, 2018
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 5, 2018
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 12, 2018
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024