23 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DMS 300-2W HOLTER ECG RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
Gibralt
FDA UDI
Choice Spine, LP·00840996169592·GIBRALT,DRILL,FIXED,3.0X14
MIRADRY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
IMHS CP
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KTT·May 29, 2013
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·September 29, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 17, 2011
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 4, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 15, 2017
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 7, 2017
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·May 15, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·August 18, 2017
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 4, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 5, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·April 11, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·April 2, 2018
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
FDA Adverse Event
Injury
·GYRUS ACMI, INC.·Product code GEI·December 16, 2025
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
FDA Adverse Event
Injury
·GYRUS ACMI, INC.·Product code GEI·December 16, 2025