28 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
FDA Enforcement
Class II
·Terminated·Arrow International Inc·September 2, 2015
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 22, 2014
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 7, 2015
Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code MRC·October 30, 2009
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
FDA Recall
Terminated
·Alivecor SFO·Product code DXH·January 9, 2015
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
FDA Enforcement
Class II
·Terminated·MEDLINE IND·January 18, 2017
AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA
FDA Recall
Terminated
·Ciba Vision Corporation·Product code MRC·November 2, 2005
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code LPN·June 30, 2009
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
FDA Recall
Terminated
·MEDLINE IND·Product code KMJ·December 12, 2016
Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code LYL·December 22, 2010
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
FDA Enforcement
Class III
·Terminated·Alivecor SFO·February 25, 2015
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
FDA Recall
Terminated
·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.
FDA Recall
Terminated
·Boston Scientific Corp·Product code FFL·December 20, 2005
IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CFL·August 9, 2010
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105.
FDA Recall
Terminated
·Boston Scientific Corp·Product code FFL·December 20, 2005
Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003
Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003
The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.
FDA Recall
Terminated
·Hospira Inc·Product code JFL·September 8, 2004
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JFL·January 29, 2020
V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
FDA Recall
Terminated
·Cardinal Health
1430 Waukegan Rd
Attn V. Mueller Qa
McGaw Park IL 60085·Product code FFL·October 27, 2004