BEUDAMED
    16 results · 42ms · Sources: EU EUDAMED, US FDA

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    STELLAR

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

    IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

    FDA 510(k)
    FDA Class 2 ·Dental

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 13, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 12, 2014

    WEB-BASED DATA MANAGEMENT

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

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD CUFF (1) COVER MAYO STAND REINFORCED (1) BAG SUTURE FLORAL (1) SHEET SPLIT WITH/ADHESIVE 108" X 77" STD SMS (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) STRIPS TAPE 24" X 4" (1) DRAPE ARTHROSCOPY W/POUCH (1) TOWEL ABSORBENT 15" X 20" 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

    UNKNOWN HIP ACETABULAR CONSTRUCT PINNACLE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·June 18, 2025

    UNK HIP ACETABULAR CUP PINNACLE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 18, 2025

    UNKNOWN HIP ACETABULAR LINERS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 18, 2025

    IH-1000 AUTOMATED ANALYZER SYSTEM

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·February 3, 2026

    C8402, M ALEXIS O WND PROT/RET 5/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code KGW·December 11, 2019

    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