19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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