204 results
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14ms
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Sources: EU EUDAMED, US FDA
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
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
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
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
Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQE·August 8, 2018
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 Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·May 9, 2014
BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code DHC·July 14, 2009
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQC·June 2, 2015
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
FDA Recall
Terminated
·Ostial Corporation·Product code LIT·July 14, 2021