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

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AART CALF IMPLANT

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

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526827899·ACHIMED ACHILLES SUPP BLACK I

APEX PS Knee

FDA UDI
Omni Life Science, Inc.·00841690113713·PS-C Insert, Size 5 x 11mm

FETALTROL

FDA 510(k)
FDA Class 2 ·Hematology

WATERLASE MILLENNIUM

FDA 510(k)
FDA Class 2 ·Dental

FAST 1.1MM DRILLBIT MINIQUICK

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HTW·June 1, 2017

XPERIM HARDWARE

FDA Adverse Event
Injury ·INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS·Product code MHX·November 4, 2021

PELVISOFT ACELLULAR COLLAGEN BIOMESH

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·March 20, 2013

M-1 COT - BASE HIGH LOAD 28

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·February 15, 2011

EXOGEN

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code LOF·March 31, 2008

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

FDA Adverse Event
Injury ·INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS·Product code MWI·November 24, 2021

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·April 7, 2021

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

FDA Adverse Event
Death ·INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS·Product code MWI·April 5, 2022

Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024