19 results · 21ms · 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.

Augmented Gingival Matrix

FDA 510(k)
FDA Class 2 ·Dental

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813058732·STERILE CARBIDE BUR FG245

OCTABONE

FDA UDI
CHIYEWON.LTD·08809490621878·

TI-OSS

FDA UDI
CHIYEWON.LTD·08809490620499·

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824876·Weisman-Graves, XXX-Long, Left Open, 20.25cm x 4cm

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code MMI·May 22, 2012

ShurFit Interbody Device

FDA UDI
PRECISION SPINE, INC.·00840019910576·25 x 12mm 5 degree O TPLIF

Scorpio

FDA UDI
Howmedica Osteonics Corp.·07613327029598·Tibial Bearing Insert - PS

STRYKER LOCKED PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

STAR 90

FDA 510(k)
FDA Class 2 ·Cardiovascular

ABUTMENT TIT. D.12

FDA UDI
SWEDEN & MARTINA SPA·D7701411593·ABUTMENT TIT. D.12 D.IMP.4.25 CLOS.0.5/SW ATTACK

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 14, 2014

S-CAL® CALIBRATOR

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code KRY·September 16, 2011

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
LAND AMERICA HEALTH & FITNESS·Product code FSA·July 26, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

FDA Enforcement
Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020