74 results
·
25ms
·
Sources: EU EUDAMED, US FDA
QUILL NONABSORBABLE NYLON BARBED SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809844450·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE SMALL ...
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106389·GIRARD FORCEPS 0.12MM RIGHT
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702590012·Elvarex 1/Knee High/Slant-Closed Toe/SoftFit-zi...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702458626·Elvarex 2/Knee High/Slant-Closed Toe-Elephantia...
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
FDA 510(k)
FDA Class 1
·Dental
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCAGE EVOLUTION SPINDLE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·October 16, 2019
ARCHITECT CA19-9XR
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·October 31, 2025
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·May 19, 2026
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·May 22, 2008
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 13, 2011
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·May 1, 2026
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·May 14, 2026
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·December 9, 2025
ARCHITECT CA19-9XR
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·December 22, 2025
ARCHITECT CA19-9XR
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·April 3, 2026
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Enforcement
Class II
·Ongoing·Merge Healthcare, Inc.·March 26, 2025