24 results · 22ms · Sources: EU EUDAMED, 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