12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMPRA HIGH POROSITY GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983064·posteriors; shade B4; size XL; upper jaw
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471130463·K-WIRE - DOUBLE TROCAR WITH GUIDE 0.6mm DIA x 1...
MASSAGE MACHINE (CAT. EM-01 ULE 111756)
FDA 510(k)
FDA Class 1
·Physical Medicine
TxTi IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
UNIVERSAL HIGH TORQUE DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·February 28, 2013
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·August 6, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code OYC·September 28, 2016
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024