BEUDAMED
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    EVOCLEAN CLEANsert Ultrasonic Insert

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777495·LUMBAMED PLUS FLEX PAD M SILVER II

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319722411·Lambert Chalazion Forceps, 3-1/2" (9.5 cm) smal...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197538374·Smith-Peterson Bone Rongeur , straight, 4mm 190mm

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197133289·Smith-Peterson Bone Rongeur straig...

    SOLUTION SYSTEM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295087083·SOLUTION SYSTEM THINSHAFT REAMER 16.5mm DIA

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197133302·Smith-Peterson Bone Rongeur straig...

    INRATIO2

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·September 25, 2009

    Safey Peak Flow Meter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FORTEX PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·January 18, 2010

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    QUADROXI D PEDIATRIC OXYGENATOR

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DTZ·August 1, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 8, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·February 16, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·August 6, 2009

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017