BEUDAMED
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    CERULEAU ELECTROSURGICAL PROBE

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

    tremoflo C2 Device - clearflo

    FDA UDI
    Thorasys Thoracic Medical Systems Inc·07540261017117·The tremoflo C2 Device - clearflo is the device...

    Luxe™ 2.5 Semi-custom loupe

    FDA UDI
    METREX RESEARCH, LLC·00850036373650·Semi-custom loupe with Luxe™ 2.5 plano oculars,...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111371202·STERILIZ FLSH TRAY 10X6 1/2X2"

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365114601·

    M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JRNY BCS PAT RESRF RD 35 MM STD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 2, 2026

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·May 9, 2013

    UNK - UNSPECIFIED BY THE COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAG·August 28, 2014

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 11, 2011

    JOURNEY POLY TIBIAL INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

    UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code LOD·February 18, 2026

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024