11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LACTOSORB MENISCAL REPAIR DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982095·posteriors; shade C3; size S; lower jaw
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Tina-quant Transferrin ver.2 (urine application)
FDA 510(k)
FDA Class 2
·Immunology
TFNA HELICAL BLADE L70 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·October 6, 2020
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 8, 2011
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·August 5, 2014
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024