16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMMA-BSM, BETA-BSM
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363291·Lucas Curette, #1R-1L
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028107·
Nitinol Stone Extractor, straight basket, 4 wires, 2.5 Fr, 90cm
FDA UDI
Promepla·03700512967729·
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
FDA 510(k)
FDA Class 2
·Orthopedic
COOK ZILVER BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERSAFITCUP DM ACETABULAR CUP 50
FDA Adverse Event
Injury
·Product code MEH·September 12, 2014
VERSAFITCUP DM SHELL 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MEH·June 26, 2015
LANX SPINOUS PROCESS FUSION PLATE
FDA Adverse Event
Injury
·LANX, INC.·Product code KWP·March 17, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·April 19, 2011
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 2022
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·September 3, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024