BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    MOTOR-DRIVE MANIPULATOR MM-89

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161075473·GRADIA® DIRECT LoFlo - 2 syringes (1.3 g/0.8 mL...

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470022911·GRADIA® DIRECT LoFlo - 2 syringes (1.3 g/0.8 mL...

    LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CHI·March 4, 2011

    CARRIAZO BARRAQUER II MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MFCD 118

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 8, 2011

    UNKNOWN DEPUY POLY ACETABULAR LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·March 13, 2013

    ROUND OSTEON BUR, ELITE, SOFT TOUCH

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS CORK·Product code HBF·January 27, 2011

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code LIT·February 22, 2008

    PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code CAH·July 18, 2023

    PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·September 6, 2023

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·October 28, 2009

    ENDOSCOPE REPROCESSOR

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FEB·March 1, 2021

    M2A-MAGNUM PF CUP 54ODX48ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 6, 2012

    LEEP PRECISION GENERATOR

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·August 19, 2022

    FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15 CARBON RIB (1) SHEET ENT SPLIT 110" X 77" SMS L/F (3) *Pr. GLOVE PERRY SURG # 7.5 LATEX (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (2) COTTON BALL MED (3) *Pr. GLOVE PERRY SURG # 7 LATEX (1) DRAPE INST. MAGNETIC 10" X 16" L/F (2) NEEDLE 30G X 1 DISP LIF (1) MARKER SKIN WITH RULER LIF (4) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) COUNTER NEEDLE AND BLADE 15C FOAM I MAG STRIP LIF (2) GOWN SOFT SMS STD X-LGE SET IN SLEEVE LIF (1) RULER 6" FLEXIBLE (1) BAG ZIP LOCK 6" X 10" PLASTIC Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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