BEUDAMED
    18 results · 33ms · 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.
    Filters Regulation: Us FDA ×

    CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier Composite Instruments

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783009811·CPF DE_1

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085022178·PVA(Zn)/10% Formalin/ETM Microvials

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003543·Dennis Micro Forceps, RH, straight, 1 mm DD rin...

    InstaFix Shape Memory Fixation System

    FDA UDI
    OT MEDICAL, LLC·B04140037240·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528104248·InstaFix Implant Kit, 25x20mm

    CARDIOSAVE HYBRID W/ E/F PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 3, 2025

    MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STIMULAN -CALCIUM SULFATE BONE VOID FILTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPIKED WASHER 13.5MM/6.5MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTN·March 14, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 24, 2011

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code MAF·February 20, 2008

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·February 12, 2018

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·February 12, 2018

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·February 12, 2018

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024