10 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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LIPASE REAGENT SET (COLIPASE METHOD)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Affinity™ Dual Arch Technique HF RS sample Kit
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010245·VPS Impression Material
artegral
FDA UDI
Merz Dental GmbH·D7091970124·anteriors; shade A4; mould BOM
RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 ABSORBABLE C0
FDA Adverse Event
MEDTRONIC SOFAMORE DANEK USA, INC.·Product code MPW·April 19, 2001
Level One Hand Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
GASTROSTOMY REPLACEMENT TUBE, MODEL 253
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2013
INTERSTIM
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·January 14, 2011
TRITANIUM REVISION ACETABULAR
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·July 31, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021