BEUDAMED
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    Pac-Dent Ceramic Nanohybrid Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319744956·Quisling Intranasal Hammer 6-1/2" (17cm)

    A-CIFT® SoloFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361037156·SLIM GUIDE, SLIM PEEK INSERTER - 12MM

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197430715·Stille Osteotome, fine model 12mm, ...

    IDS-ISYS IFG-I CONTROL SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FLEXIBLE ENDOSCOPIC SCISSORS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEPTHALON®

    FDA UDI
    PMT CORPORATION·00650551095880·MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CON...

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code QFG·July 21, 2021

    MEDLINE UNITE

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025

    DEPTHALON®

    FDA UDI
    PMT CORPORATION·00650551096023·MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CON...

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 29, 2014

    EON MINI RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 9, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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