19 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304507548·
SHIMADZU COLLIMATOR R-300
FDA 510(k)
FDA Class 2
·Radiology
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
ERBE VIO 300 D
FDA Adverse Event
Injury
·ERBE USA, INC.·Product code GEI·November 3, 2008
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
ORTHOPEDIC SALVAGE SYSTEM SMOOTH STRAIGHT IM STEM 11MM X 150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 29, 2025
MAK ORTHOPEDIC SALVAGE SYSTEM RS DISTAL FEMORAL COMPONENT LEFT 8.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·May 29, 2025
CPS CENTERING SLEEVE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·January 20, 2020
CPS NUT CO-CR-MO ALLOY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·January 20, 2020
CPS TRANSVERSE PIN 6PK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 20, 2020
CPS TAPER LOCKING CAP / OSS SC
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 5, 2018
OSS RS NON MOD PLATE LONG 67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 5, 2018
CPS 10CM SEG FM OSS TPR LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·October 23, 2017
OSS RS POLY TIBIAL BEARING 14
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·October 8, 2018
OSS TO CPS EXP INTERCA SEG 6CM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·January 18, 2023
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016