19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BD SINGLE USE, HYPODERMIC SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BD LUER SLIP¿ TUBERCULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 27, 2021
ADVIA Centaur® DIG
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177410·Digoxin - CENTAUR - RGT - 50 tests
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803604·Bookwalter Tray for Rings & Posts: 330 x 558 x ...
Vaginal CT/MR Multi Channel Applicator
FDA UDI
Nucletron B.V.·08717213022461·Fixation Screw Set
PERIOLASE ND:YAG DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RELINE-IT MODEL RELINE-IT
FDA 510(k)
FDA Class 2
·Dental
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 1, 2011
BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·September 27, 2021
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·July 25, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
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