BEUDAMED
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    STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    NuOss XC Sinus

    FDA UDI
    COLLAGEN MATRIX, INC.·00813954027999·Self-Expanding Composite

    NuOss

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950007332·NUOSS XC SINUS 17X10MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776087142·Gregory Bulldog Clamp

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180507865·Thinner Invictus OCT Straight Gearshift Probe, ...

    Proximal Humeral Fracture Plate System

    FDA UDI
    Smith & Nephew, Inc.·00885556829660·HFP TRAY BASE

    Integra®

    FDA UDI
    Ascension Orthopedics, Inc.·10381780364825·Proximal Humeral Fracture Plate System Tray Base

    METHADONE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GRAMS SILK NONABSORBABLE SUTURE

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

    100" 20 DROP Y-TYPE BLOOD SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 8, 2016

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 3, 2013

    RAD-8 HORIZONTAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·September 5, 2014

    ACTIVA SC

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·May 5, 2011

    ACCESS FAST HTSH REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code JLW·March 18, 2015

    100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration

    FDA Enforcement
    Class II ·Terminated·Collagen Matrix Inc·March 23, 2016

    106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code FPA·December 24, 2013

    NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration

    FDA Recall
    Terminated ·Collagen Matrix Inc·Product code NPM·May 13, 2013