406 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PAIRED HYDROGEL ELECTRODE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306815539·Ribbon Retractor, Malleable, Width: 38 mm, Leng...

Posted Stainless Steel Archwire

FDA UDI
Ortho Arch Company Inc·D90911013811·.018 POSTED SS RIGHT FORM WIRES 38MM (10)

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450292464·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450293027·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450292259·

3.8 x 230 mm Surgibit Drill

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055103·The saleable unit (device count) is 1, there ar...

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PROFILE II ER

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·July 30, 2014

TRIATHLON PS X3 TIBIAL INSERT

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2013

COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·September 23, 2014

COULTER® LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 1, 2011

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 17, 2025

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 19, 2025

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code NJR·April 17, 2026

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 14, 2026

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026