21 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

HARDYDISK CEFOPERAZONE, 75 MCG

FDA 510(k)
FDA Class 2 ·Microbiology

Implant Prosthetics

FDA UDI
Preat Corporation·00842092133088·Straumann® BL-compatible NC/RC Muti-Unit Titani...

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964013650·Endo Carry-On Procedure Kit includes Essential ...

Implant Prosthetics

FDA UDI
Preat Corporation·00842092116838·Straumann® BL NC/RC-compatible Multi-Unit Titan...

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001489·artVeneer life lower anteriors, UBIL, D3

POLYMACON

FDA 510(k)
FDA Class 2 ·Ophthalmic

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST

FDA 510(k)
FDA Class 2 ·Immunology

BD SYRINGE 3ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 7, 2025

LIGACLIP MCA

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDO·February 25, 2013

ENGEN LABORATORY AUTOMATION SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·February 25, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·February 19, 2008

BD SYRINGE 5ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 7, 2025

BD SYRINGE 1ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 7, 2025

BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

FDA Adverse Event
Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 20, 2017

Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

FDA Enforcement
Class II ·Terminated·Oxus America, Inc.·February 13, 2013

Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

FDA Enforcement
Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024