10,000 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
FDA Recall
Terminated
·SCC Soft Computer·Product code JQP·February 23, 2006
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·June 1, 2022
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
FDA Enforcement
Class III
·Terminated·Convatec Inc.·August 28, 2013
ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
FDA Enforcement
Class III
·Terminated·Convatec Inc.·August 28, 2013
SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
FDA Recall
Terminated
·SCC Soft Computer·Product code JQP·January 9, 2001
OTC Pregnancy Test labeled ''CHOICE Pregnancy Test Kit'' (PA-410A), midstream, no cups or droppers. Label reads: ''One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by ICC, Amherst, NY 14228.
FDA Recall
Terminated
·International Chemical Inc.·Product code LCX·October 7, 2004
OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228
FDA Recall
Terminated
·International Chemical Inc.·Product code LCX·October 7, 2004
ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch
FDA Recall
Terminated
·Convatec Inc.·Product code EZQ·September 17, 2010
AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.
FDA Recall
Terminated
·Qualitest Pharmaceuticals Inc·Product code FMF·June 14, 2005
Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare. Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock or saline lock.
FDA Recall
Terminated
·Ulti Med, Inc.·Product code FMF·February 5, 2010
NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). JD+01U3008-5C 1cc 30G x 5/16"; JD+01U3013-5C 1cc 30G x 1/2"; JD+01U3108-5C 1cc 31G x 5/16"; JD+03U3008-5C .3CC 30 g X 5/16"; JD+03U3013-5C .3CC 30 g X 1/2"; JD+03U3108-5C .3cc 31G x 516"; JD+05U3008-5C .5cc 30G x 5/16"; JD+05U3013-5C .5cc 30G x 1/2"; JD+05U3108-5C .5cc 31G x 5/16".
FDA Recall
Terminated
·Nipro Medical Corporation·Product code FMF·January 13, 2010
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler
FDA Enforcement
Class II
·Terminated·Surgical Tissue Network, Inc.·January 16, 2013
Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" Origen DBM with Bioactive Glass Catalog #: 22-2002 (2cc size) 22-2005 (5cc size) 22-2010 (10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
FDA Recall
Terminated
·Nanotherapeutics, Inc·Product code MQV·March 10, 2011
Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" NanoFUSE DBM Catalog #: NAN109-02 (2cc size) NAN109-05 (5cc size) NAN109-10(10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
FDA Recall
Terminated
·Nanotherapeutics, Inc·Product code MQV·March 10, 2011
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler
FDA Recall
Terminated
·Surgical Tissue Network, Inc.·Product code MQV·March 14, 2012
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·June 5, 2019
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc.·March 22, 2017
OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
FDA Recall
Terminated
·Exactech, Inc.·Product code MQV·April 26, 2019
Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003