75 results
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16ms
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Sources: EU EUDAMED, US FDA
AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
FDA Recall
Terminated
·AmeriWater Inc·Product code FIP·August 9, 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
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
FDA Recall
Terminated
·MRP, LLC dba AMUSA·Product code NGT·April 27, 2015
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
FDA Recall
Terminated
·MRP, LLC dba AMUSA·Product code NGT·July 2, 2015
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
FDA Recall
Terminated
·MRP, LLC dba AMUSA·Product code NGT·February 9, 2015
Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MJK·June 30, 2006
Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Manufactured by MRL Inc., a WelchAllyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089-Part Numbers-971081,971082,971083,971084.
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MJK·November 15, 2006
Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ--·April 26, 2004
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ·June 15, 2006
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ·April 28, 2005
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