BEUDAMED
    213 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    NuOSS Cancellous Intended for use in dental surgery.

    FDA Recall
    Terminated ·Collagen Matrix Inc·Product code NPM·August 25, 2015

    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar 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 the maxillary sinus floor, etc.

    FDA Recall
    Terminated ·Geistlich Pharma North America, Inc.·Product code NPM·April 12, 2019

    Porcine Anorganic Bone Mineral 4.0cc

    FDA Recall
    Terminated ·Collagen Matrix Inc·Product code NPM·October 30, 2018

    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation or reconstructive treatment of the alveolar 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 the maxillary sinus floor, etc.

    FDA Recall
    Terminated ·Geistlich Pharma North America, Inc.·Product code NPM·April 12, 2019

    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmentation or reconstructive treatment of the alveolar 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 the maxillary sinus floor, etc.

    FDA Recall
    Terminated ·Geistlich Pharma North America, Inc.·Product code NPM·April 12, 2019

    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

    Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116

    FDA Recall
    Terminated ·Geistlich Pharma North America, Inc.·Product code NPM·October 19, 2020

    Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126

    FDA Recall
    Terminated ·Geistlich Pharma North America, Inc.·Product code NPM·October 19, 2020

    ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -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 -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

    FDA Recall
    Terminated ·Collagen Matrix Inc·Product code NPM·November 17, 2015

    Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115

    FDA Recall
    Terminated ·Geistlich Pharma North America, Inc.·Product code NPM·October 19, 2020

    CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·May 28, 2014

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·April 6, 2016

    Capnostream20 M NICU (CPM), CS08654RN

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Capnostream20 M ADULT ICU (CPM), CS08654RA

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 7, 2021

    PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5250, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5300 PowerPro Battery Oscillator Handpiece. PRO 5300 Oscillator Speed Range: 0-11,000 cpm, and PRO5400 PowerPro Battery Reciprocator Handpiece. Speed Range: 0-14,500 cpm+/- 500 cpm. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HRX·July 31, 2009

    Capnostream20 M NICU (CPM), CS08654RN

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 M ADULT ICU (CPM), CS08654RA

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HQE·August 8, 2018

    Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HQE·August 8, 2018