15 results
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20ms
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Sources: EU EUDAMED, US FDA
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033657·Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEu...
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
SIEMENS INFINITY GATEWAY SUITE, MODEL VF2
FDA 510(k)
FDA Class 2
·Cardiovascular
ACQSIM CT SCANNER
FDA Adverse Event
Malfunction
·PHILIPS·Product code JAK·August 12, 2014
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010
BD ULTRA-FINE¿ PRO PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 4, 2021
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 3, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 25, 2014
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011
Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 software. The Brilliance Big Bore and Brilliance 64 are Computed Tomography X-Ray Systems intended thio product cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017