15 results · 19ms · Sources: EU EUDAMED, US FDA

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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