23 results · 26ms · Sources: EU EUDAMED, US FDA

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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