BEUDAMED
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    Sapphire NC 24

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SCS CLARIS SPINAL SCREWS, TYPES V,G,E

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN NEXGEN LPS-FLEX KNEE IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·March 20, 2015

    UNK NEXGEN LPS-FLEX KNEE IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 20, 2015

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025

    ASR UNI FEMORAL IMPLANT SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

    HIP 5.0MM CANNULA

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY-SAN JOSE·Product code NBH·October 29, 2014

    TALENT TAA

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·July 8, 2013

    COVEREDGE 32

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 28, 2024

    Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025

    Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21-1817-01/50

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code GEI·August 21, 2025

    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

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025