18 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Immage Antidioxyribonuclease B (DNB) reagent part no. 447480
FDA Recall
Terminated
·Beckman Coulter Inc·Product code EXEMP·January 29, 2003
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
FDA Recall
Terminated
·Micro-Tech (Nanjing) Co., Ltd.
High Tech
NO. 10 Gaoke Third Road Nanjing National
Nanjing China·Product code ODG·March 12, 2018
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
FDA Enforcement
Class II
·Terminated·Micro-Tech (Nanjing) Co., Ltd.·May 23, 2018
HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007
Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx) Material/UPN/Catalog Number: M006560201 System-HTA System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea) Material/UPN/Catalog Number: M006560200 Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code MNB·July 31, 2009
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
FDA Recall
Terminated
·Hologic, Inc·Product code MNB·January 24, 2014
Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a component in the Difco(tm) "Shigella Grouping Antiserum Set", Cat. 241108, Lot 6073806). Vials are labeled in part ***S. flexneri Serotypes 1-6***Becton, Dickinson and Company Sparks, MD 21152*** Used for the identification of Shigella species by the slide agglutination test.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code GNB·November 30, 2007
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
FDA Recall
Terminated
·Perkinelmer·Product code JNB·November 26, 2012
HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007
HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007
Adapter for ACMI Hysteroscope Catalog Number: 55035
FDA Recall
Terminated
·Boston Scientific Marlbourgh·Product code MNB·July 28, 2005
Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratories, Hercules, CA
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code JNB·January 26, 2010
Boston Scientific HydroThermAblator Endometrial Ablation System- HTA Procedure Set (5/bx) Material/UPN/Catalog Number: M006550161 Boston Scientific HydroThermAblator Endometrial Ablation System-HTA Procedure Set (ea) Material/UPN/Catalog Number: M006550160 Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code MNB·July 31, 2009
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
FDA Recall
Terminated
·Remel Inc·Product code GNB·December 8, 2017
HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007
Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** Used for the identification of Shigella species by the slide agglutination test
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code GNB·November 30, 2007
her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.
FDA Recall
Terminated
·American Medical Systems·Product code MNB·January 13, 2006
HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007