BEUDAMED
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    AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NuOss XC Sinus

    FDA UDI
    COLLAGEN MATRIX, INC.·00813954028002·Self-Expanding Composite

    NuOss

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950007349·NUOSS XC SINUS 22X12MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776087159·Gregory Bulldog Clamp

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776154523·Gregory Bulldog Clamp Curved Left JW 3mm, JL 60...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450390351·

    TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123

    FDA 510(k)
    FDA Class 2 ·General Hospital

    2008T HEMODIALYSIS SYS., WITH CDX

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 26, 2018

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 3, 2013

    LNOP NEO-L

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

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code MND·April 15, 2011

    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

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025