16 results · 29ms · 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.

FS ACTIVATOR III

FDA 510(k)
FDA Unclassified ·Unknown

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964022416·The ENDO CARRY-ON Procedure Kit contains all of...

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·H65810031851·Ultra Clean L

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159002898·Jacobson Micro Needle Holder Round Handle

INSET 30

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CPS SHRT LG DRILL GUIDE 5 HOLE

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code FZX·May 23, 2022

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

D903 DIDECO AVANT

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·February 15, 2011

UNK

FDA Adverse Event
Injury ·UNK·Product code JWH·February 22, 2008

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024