BEUDAMED
    20 results · 21ms · 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 ×

    INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180

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

    SILVERVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948011029·SILVERVENT 1 ICU, SIZE 5

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114724·LOCATOR F-Tx Abutment for Narrow Platform (NP) ...

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025200·PREF ARCH NI-TI LOWER 16 SMALL PK10

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110535·LOCATOR R-Tx Abutment for Narrow Platform (NP) ...

    Batrik Brush/White/BD 5mm/BL 50mm

    FDA UDI
    Batrik Medical Manufacturing Inc·00690521007680·Brush/White/BD 5mm/BL 50mm/OL 50cm - Symetric D...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481128691·LOCATOR R-Tx Abutment, Narrow Platform (NP) Tri...

    CYNOSURE PHOTOGENICA DL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    A&E MEDICAL CORPORATION - SUCTION COAGULATOR

    FDA Adverse Event
    Injury ·A&E MEDICAL CORPORATION·Product code FEH·August 10, 2017

    NI

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 12, 2006

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 10, 2013

    OASYS 3.5 X 20MM POLYAXIAL SCREW

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·March 25, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 8, 2008

    AE MEDICAL CORP.

    FDA Adverse Event
    Malfunction ·AE MEDICAL CORP·Product code GEI·November 26, 2003

    SUCTION COAGULATOR

    FDA Adverse Event
    Malfunction ·A&E MEDICAL CORPORATION·Product code GEI·January 21, 2021

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-82.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015