BEUDAMED
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    Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776305420·Hibbs Osteotome 9.5" Cvd 38"

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188193·Integra® Jarit® Hibbs Osteotome, 9-1/2", Curved...

    SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY

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

    Venus Viva SR Device

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

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 15, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 14, 2014

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013