13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOMARC FIDUCIAL MARKER
FDA 510(k)
FDA Class 2
·Radiology
ADVIA Centaur® DIG +B
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177427·Digoxin - CENTAUR - RGT - 250 tests
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
FDA 510(k)
FDA Class 2
·Radiology
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
BD LUER SLIP¿ TUBERCULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·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
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023