16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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