69 results
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21ms
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Sources: EU EUDAMED, US FDA
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code GRO·October 22, 2012
Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KRA·August 24, 2009
Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·February 26, 2010
life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007
life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
FDA Recall
Terminated
·Covidien LLC·Product code DRO·April 8, 2013
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
FDA Recall
Terminated
·Bard Access Systems·Product code FRO·November 3, 2014
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
FDA Recall
Terminated
·Covidien LLC·Product code DRO·August 19, 2015
Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
FDA Recall
Terminated
·Conseal International, Inc.·Product code FRO·April 25, 2018
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FRO·March 6, 2018
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
FDA Recall
Terminated
·Southwest Technologies Inc·Product code FRO·November 18, 2019
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020
D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat 2 Dry hemostatic bandage (D-Stat 2 Dry) consists of the following components: -One (1) scored lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride; -Two (2) Adhesive bandages.
FDA Recall
Terminated
·Vascular Solutions, Inc.·Product code FRO·September 9, 2005
ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
FDA Recall
Terminated
·Integra Biotechnical LLC·Product code FRO·February 1, 2007
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FRO·September 15, 2005
Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy
FDA Recall
Terminated
·TZ Medical, Inc.·Product code FRO·July 7, 2016
ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
FDA Recall
Terminated
·Advanced Medical Solutions Ltd. Premier·Product code FRO·January 15, 2015
smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
FDA Recall
Terminated
·Z-Medica, LLC·Product code FRO·September 22, 2021