17 results · 39ms · Sources: EU EUDAMED, US FDA

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3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

FDA 510(k)
FDA Class 2 ·Ophthalmic

ACE

FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950025336·6' DISS SWIVEL TO PURITAN MALE OXYGEN HOSE ASSE...

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573021369·INTRG WHISP MBT CUS HK0T +8A 018 UL

SCANLUBE

FDA 510(k)
FDA Class 2 ·Radiology

AMPCARE ESP THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD LUER-LOK¿ SYRINGE STERILE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 10, 2022

BD INTIMA-II CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·April 9, 2021

RIGID OPTICAL STONE CRUSHING FORCEP 30 DEGREE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·July 25, 2011

ACCENT DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·November 6, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 17, 2013

INTIMA-II Y 24GAX0.75IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·December 17, 2020

BD INTIMA-II CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·December 28, 2020

BD INTIMA-II CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·December 16, 2020

ARCTIC SUN® 5000

FDA Adverse Event
Malfunction ·MEDIVANCE -1725056·Product code DWJ·December 2, 2025

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

FDA Enforcement
Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020