BEUDAMED
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    Surgical Mask

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

    Anti-D (RH1) IgG

    FDA UDI
    DIAGAST·23661562105247·Blood Grouping Reagent, Anti-D (Human/Murine Mo...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180132627·5 MM DIA., 45 CM INSULATED SUCTION COAGULATOR W...

    SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·March 16, 2021

    ENDURON NEUT 54OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HRY·October 22, 2008

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·August 10, 2011

    FORTIFY DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    EXPRESSEW III W/HOOK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code LXH·October 13, 2021

    RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"

    FDA Enforcement
    Class II ·Terminated·Reflexion Medical, Inc.·January 19, 2022

    Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·February 2, 2022

    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

    FDA Enforcement
    Class II ·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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