BEUDAMED
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    PROTEIN C REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040062548·Endoflex Reamers 21 mm

    t:slim Cartridge, t:lock, 10 Pack

    FDA UDI
    Tandem Diabetes Care, Inc.·00853052007776·t:slim Cartridge, t:lock, 10 Pack

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103933·BRACKET MEDIUM TWIN LEFT CENTRAL 018 TQ=+15 A=+...

    SILK NONABSORBABLE SURGICAL SUTURES, USP

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

    MINICAM

    FDA 510(k)
    FDA Class 1 ·Dental

    REMSTAR PLUS C-FLEX

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·December 1, 2023

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·August 10, 2023

    GREENFIELD¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code DTK·March 13, 2013

    PARAGIGM REAL TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 16, 2011

    AXIUM 3D DETACHABLE COIL

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code HCG·February 26, 2008

    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

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·September 25, 2024

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024