15 results
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19ms
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Sources: EU EUDAMED, US FDA
AESKULISA ANA HEP-2, REF 30-7115US
FDA 510(k)
FDA Class 2
·Immunology
Keystone HB
FDA UDI
Keystone Industries·H66860811041·HB Bite Registration Fast Set
PureLife Dental
FDA UDI
PURELIFE, LLC·D79010811041·Lilac "B" Ritter Tray Covers, 8 1/2" x 12 1/4",...
OSTEOBELL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDERED VINYL EXAM GLOVES, WHITE
FDA 510(k)
FDA Class 1
·General Hospital
VERCISE GENUS¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·January 14, 2022
BD BBL¿ XLD AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code JSJ·July 24, 2023
SYSTEM 6 ASEPTIC HOUSING ASSY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·April 26, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 14, 2011
RIGHT TOTAL SHOULDER ARTHROPLASTY
FDA Adverse Event
Injury
·UNK·Product code HSD·July 23, 2008
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx
FDA Recall
Terminated
·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·April 2, 2004
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012