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    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 20, 2015

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185503·AccuFit™ Molar Band UR7 - 35.5

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551136309·HALO, 1203-5 VEST X-LARGE, LAMBSWOOL LINER, 121...

    Proximal Humeral Plate

    FDA UDI
    I.T.S. GmbH·09120069813579·Proximal Humeral Plate, SAP Flange, Large, 5-Hole

    ECHOBRIGHT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIOLIGHT PCD

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 20, 2015

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 24, 2015

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 3, 2015

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 22, 2008

    EZ-PRO R4 AMBUL COT

    FDA Adverse Event
    Other ·STRYKER MEDICAL·Product code FPO·August 3, 2011

    ASPHERE M SPEC 12/14 36 +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 8, 2013

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 3, 2015

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), 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);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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