111 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.
FDA Enforcement
Class II
·Terminated·SALTER LABS·July 4, 2012
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
FDA Enforcement
Class II
·Terminated·Salter Labs·July 30, 2014
NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
FDA Enforcement
Class II
·Terminated·Salter Labs·September 23, 2015
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
FDA Enforcement
Class II
·Terminated·SALTER LABS·November 27, 2013
T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
FDA Enforcement
Class II
·Terminated·Salter Labs·February 17, 2016
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
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
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
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
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
FDA Enforcement
Class II
·Terminated·Wexford Labs Inc·November 27, 2013
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
FDA Enforcement
Class III
·Terminated·Lab Vision Corporation·February 24, 2016
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
FDA Enforcement
Class II
·Terminated·Lab Vision Corporation·January 22, 2014
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
FDA Enforcement
Class III
·Terminated·Lab Vision Corporation·December 2, 2015
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.
FDA Enforcement
Class II
·Terminated·Miramar Labs, Inc.·November 18, 2015
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Ansh Labs, LLC·January 20, 2021
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.
FDA Recall
Terminated
·SALTER LABS·Product code CCK·May 30, 2012