17 results · 20ms · 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.

RENEW LS-2

FDA 510(k)
FDA Class 2 ·Dental

Premier Elevator

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004052·ELEVATOR 302 B

Premier Elevator

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004076·ELEVATOR 304 B

Implant Prosthetics

FDA UDI
Preat Corporation·00842092102930·CAMLOG® Screw-Line-compatible 3.8mm X 4.5mm Tit...

3M™ Unitek™ APC™ Clarity™ MBT™

FDA UDI
3M UNITEK CORPORATION·00652221237040·APC FF Clarity Ultra SL MBT L Lt 2nd Bicusp -17...

3M™ Unitek™ Clarity™ MBT™

FDA UDI
3M UNITEK CORPORATION·00652221287403·Clarity Ultra SL Bkt MBT L Lt 2Bicuspid -17T/2A...

SILHOUETTE

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 21, 2025

JILCO TRACTION-FLEXION CHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

K-ASSAY AT-III

FDA 510(k)
FDA Class 2 ·Hematology

PROSTHESIS, HIP

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

SMALL ELECTRIC DRIVE

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

HEX STARDRIVE SCREWDRIVER

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HXX·February 28, 2013

EXTENSION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 1, 2011

GURADIAN 4000 WHEEL CHAIR

FDA Adverse Event
Other ·A & E·Product code IOR·February 6, 2008

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

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

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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