15 results · 20ms · Sources: EU EUDAMED, US FDA

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TORNIER INSITE FT SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

ADVIA Centaur® CKMB

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177434·CKMB Mass - CENTAUR - RGT - 100 tests

Vaginal CT/MR Multi Channel Applicator

FDA UDI
Nucletron B.V.·08717213022447·Perineal Bar Set

22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 20, 2017

KAI SPOT MODEL KMS 200

FDA 510(k)
FDA Class 2 ·Anesthesiology

BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

BD LUER SLIP¿ TUBERCULIN SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018

BD INSULIN PEN NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

FREESTYLE LITE

FDA Adverse Event
Injury ·Product code NBW·June 1, 2011

SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·January 27, 2021

Video Duodenoscope

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·June 8, 2016

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021