15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NON-CONTACT TEAR FILM THERMOGRAGH
FDA 510(k)
FDA Class 2
·Ophthalmic
ARGELOY NP STAR (250g)
FDA UDI
ARGEN CORPORATION, THE·D818111771·Base metal alloy
RANDOX THEOPHYLLINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RELINE-IT MODEL RELINE-IT
FDA 510(k)
FDA Class 2
·Dental
JRNY BCS PAT RESRF RD 35 MM STD
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017
BD LUER SLIP¿ TUBERCULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·April 25, 2013
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 23, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·May 25, 2011
JOURNEY POLY TIBIAL INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 27, 2021
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IZH·November 16, 2005
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021