15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NO-PROFILE
FDA UDI
Biomet Sports Medicine, LLC·00880304406001·
Implant Analog (AY) Stainless Steel
FDA UDI
STERNGOLD DENTAL LLC·00841549117367·Used to replicate the position of the implant i...
Valencia Pedicle Screw System
FDA UDI
Altus Spine, LLC·B41799045451·4.5mm x 45mm Dual Lead Closed Head Screw
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014810·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111187940·5000 CLAW FCPS 45CM 5MM
O-RING PROSTHETIC ATTACHMENT DEVICE
FDA 510(k)
FDA Class 2
·Dental
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 23, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 26, 2020
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code OAE·December 22, 2015
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code MCX·November 22, 2010
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NIK·July 1, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 4, 2012
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 25, 2025