BEUDAMED
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    HydroMARK Breast Biopsy Site Marker

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

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

    Posterior Pelvic Wall Plate II, Right

    FDA UDI
    I.T.S. GmbH·09120047302279·Posterior Pelvic Wall Plate II, Right, 8-Hole, ...

    Origin Stem Size 8 Template

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055875·

    MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: LONG LENGTH GAMMA NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOLDING SLEEVE

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HXX·April 20, 2020

    CONCERTO

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·December 18, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 29, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 8, 2013

    EXAFIT T4.1

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·November 9, 2015

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QMN·January 29, 2023

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QMN·January 29, 2023

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QMN·January 29, 2023

    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·June 14, 2023

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    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