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