21 results · 25ms · Sources: EU EUDAMED, US FDA

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Stryker Resorbable Fixation System

FDA 510(k)
FDA Class 2 ·Neurology

ELMED

FDA UDI
ELMED INCORPORATED·00842180160958·PRISM CERVICAL CURETTE 10" ANGLED 90° 6, BLACK

BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,

FDA 510(k)
FDA Class 2 ·Ophthalmic

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

FDA 510(k)
FDA Class 2 ·Immunology

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·December 20, 2021

BD INTIMA II¿ IV CATHETER PRN ADAPTER

FDA Adverse Event
Malfunction ·Product code FOZ·October 4, 2021

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 10, 2008

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·July 18, 2011

TITANIUM ROOF PILE SCREW 35MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDJ·July 17, 2013

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·July 14, 2021

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026