BEUDAMED
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    IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

    FDA 510(k)
    FDA Class 1 ·Dental

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113516·MINIATURE BLADE #69 (BX/5)

    V-Sono Intracardiac Echo Manipulator

    FDA UDI
    Stereotaxis, Inc.·M58800100246910·Vdrive with V-Sono is indicated for remotely co...

    R&D PROJECT DW269#25

    FDA 510(k)
    FDA Class 2 ·Dental

    RANDOX COMPLEMENT C3

    FDA 510(k)
    FDA Class 2 ·Immunology

    DA VINCI ROBOTICS SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 13, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·February 16, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·February 20, 2008

    Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016

    Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·April 20, 2016

    BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE SHEET 41" X 58" SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44" X 78" (2) GOWN SOFT SMS STD, XLGE SET IN SLEEVE 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

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019