BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    HARDYDISK LOMEFLOXACIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126601·

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015

    MALLORY HEAD MODULAR CALCAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 18, 2025

    Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER (1) UNDERPAD 23 X 36 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

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·February 13, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 8, 2011

    ACCU-CHEK ACTIVE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2008

    Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER (1) UNDERPAD 23 X 36 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014

    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