27 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex SynergyID Endoscopic Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TIMX
FDA UDI
Medos International Sàrl·10705034000589·TIMX LOW BACK SYSTEM DEPTH GAUGE 0-60mm Plus or...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112670·BARRON CORNEAL PUNCH 9.0MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133005·LATERAL,NERVE RETRACTOR,90 DEG
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 22, 2014
LONG NAIL KIT R1.5, TI, LEFT 10X340MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 8, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 18, 2014
VALIANT CAPTIVIA UNK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 8, 2025
COBAS® HIV-1 (192T)
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code MZF·September 19, 2025
ACRYSOF MULTIPIECE IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·July 31, 2025
ACRYSOF SINGLEPIECE IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·July 31, 2025
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·July 8, 2015
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 15, 2015
TIMX SCW DEPTH GAUGE
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code HTJ·February 10, 2025
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 26, 2013