24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SelectFlex 072 Neurovascular Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
Arthrex®
FDA UDI
ARTHREX, INC.·00888867543188·Foot Rocker, Short
MultiPulse HoPLUS
FDA UDI
Asclepion Laser Technologies GmbH·04058784001054·Holmium Laser for Surgery (100W-75Hz)
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641219·Semi-automatic Disposable Biopsy Needle
Immunalysis
FDA UDI
IMMUNALYSIS CORP·00840937109021·Fentanyl Antibody Analyte Specific Reagent (ASR)
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641325·Semi-automatic Disposable Biopsy Needle
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641363·Semi-automatic Disposable Biopsy Needle
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
WELLMIEN SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·July 7, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 20, 2013
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 29, 2008
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·September 19, 2018
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·March 8, 2021
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE
FDA Adverse Event
Injury
·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019
TENSIONER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·November 8, 2021
60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·February 16, 2026
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·October 14, 2019
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013