18 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.

SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS

FDA 510(k)
FDA Class 2 ·Dental

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810057372223·SKYTRON TRANSFER BOARD COVER

Symmetry Malis®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139790·Symmetry® Forceps; Bayonet Bipolar; 1.5 mm Tips...

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331118920·MALIS Non-Stick Mirror Finish Bipolar Forceps, ...

Symmetry Olsen

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00841785112805·

Disposable Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935105305·

REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)

FDA 510(k)
FDA Class 2 ·Neurology

SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

SKYTRON PATIENT POSITIONER

FDA Adverse Event
Injury ·SCHUERCH CORPORATION·Product code FWZ·March 6, 2024

WAVEWRITER ALPHA? PRIME 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 28, 2026

22 G X 1.00 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 8, 2017

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013

7F PEDI CATH LAB INTRODUCER

FDA Adverse Event
Malfunction ·ARGON MEDICAL DEVICE, INC.·Product code DRE·April 6, 2011

OLYMPUS

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDI·July 17, 2008

BD INTIMA-II 24GAX0.75IN

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·November 1, 2023

2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014