327 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

FDA Recall
Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

FDA Recall
Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.

FDA Recall
Terminated ·Product code NBE·July 28, 2011

COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

FDA Recall
Terminated ·Baxter Healthcare Corp·Product code NBE·May 12, 2016

Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code NBE·December 6, 2023

Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

FDA Recall
Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.

FDA Recall
Terminated ·Mallinckrodt Manufacturing LLC·Product code NBE·October 17, 2014

Baxter Preveleak Surgical Sealant, Product Codes: ADS201808

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code NBE·December 6, 2023

Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.

FDA Recall
Terminated ·Neomend Inc·Product code NBE·August 13, 2012

COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

FDA Recall
Terminated ·Baxter Healthcare Corp·Product code NBE·May 12, 2016

COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

FDA Recall
Terminated ·Baxter Healthcare Corp·Product code NBE·May 12, 2016

BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.

FDA Recall
Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSI·June 6, 2013

BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

FDA Recall
Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

FDA Recall
Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

FDA Recall
Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

FDA Recall
Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code LOM·November 1, 2018

BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

FDA Recall
Terminated ·Prism Medical Services USA·Product code FSA·May 23, 2013

Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

FDA Recall
Terminated ·RF Technologies, Inc.·Product code KMI·May 17, 2013

INZONE DETACHMENT SYSTEM, REF: M00345100950

FDA Recall
Open, Classified ·Stryker Neurovascular·Product code HCG·April 6, 2026

Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

FDA Recall
Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012