18 results · 23ms · Sources: EU EUDAMED, US FDA

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INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

PULSE

FDA UDI
Nuvasive, Inc.·00887517994134·PULSE Flat Array B, Beta

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496050131·RED WELLNESS 70 LEGGINGS, SIZE ML, MOSTO, GRADU...

MedGyn Pessary Dish w/o support # 2

FDA UDI
MEDGYN PRODUCTS, INC.·M803050131·Dish Pessary is used to treat uterine prolapse.

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812583·Mayo Scissors, Straight, 25cm

PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SELUTE PICOTIP

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·April 10, 2013

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

PERCLOSE

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR DEVICES·Product code MGB·May 9, 2008

BD FACS 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Enforcement
Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Enforcement
Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Recall
Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Recall
Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018