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    Diode Laser Machine, Model Number: BM-100

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

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551136132·HALO, 1203-5 VEST X-LARGE, COOLMAX LINER, 1211-...

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185466·AccuFit™ Molar Band UR7 - 33.5

    SYNTHS ONE-THIRD TUBULAR DCL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·October 22, 2008

    INTERTAN

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDS·August 15, 2011

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·February 16, 2026

    Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.

    FDA Recall
    Terminated ·Orthofix, Inc·Product code MQP·November 19, 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

    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

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 6, 2025