BEUDAMED
    26 results · 23ms · Sources: EU EUDAMED, US FDA

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    PRESSON ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551038702·2 PIECE BUSHING FOR DEPTH, FOR VERTEK AND BRAINLAB

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113783·AIR INJECT CANNULA 25GA

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434519·Tasso+ allows self-collection of a capillary bl...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319736739·Sewall Orbital Retractor 6-3/4" (17cm), 7mm x 5...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197202510·RZ Double Clamp, Vein 16mm, ...

    POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SPECIALTY ASSAYED CONTROL-2

    FDA 510(k)
    FDA Class 2 ·Hematology

    PROGAV®

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018

    Smart Correction

    FDA UDI
    Wishbone Medical, Inc.·B56250103103WB0·Dual Joint Standard Strut, Medium - Non-Sterile

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MCX·May 9, 2013

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LFX·May 25, 2011

    PERFIX PLUG

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 8, 2008

    CLW INSERT 32 WITH RIM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 27, 2019

    Mitek Screw and Washer Depth Gauge, Product Code 219024

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2018

    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code DHR·November 9, 2001

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019