19 results
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18ms
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Sources: EU EUDAMED, US FDA
ACL TOP MODEL, TOP
FDA 510(k)
FDA Class 2
·Hematology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033414·Baltic Denture System BDLoad BDLoad Mm7 PLSEbi...
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 25 x 5.5 x 0.56mm
FDA UDI
SURETEK MEDICAL·B390KM334141·
Brasseler USA
FDA UDI
Provision·00810041064998·
Brasseler USA
FDA UDI
Provision·B504OMKM334140·
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094319·KM33-414
NA
FDA UDI
STERILMED, INC.·10888551017145·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134140·Trial, TLIF, 27L OB STR 7Deg, 14mm
Stryker
FDA UDI
Provision·B504OM22960334140·
Stryker
FDA UDI
Provision·00810041634351·
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
FDA 510(k)
FDA Class 2
·Immunology
MIDA ALGORITHM REV. B
FDA 510(k)
FDA Class 2
·Cardiovascular
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 3, 2013
PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXZ·March 24, 2011
SONICARE ESSENCE
FDA Adverse Event
Malfunction
·PHILIPS ORAL HEALTHCARE·Product code JEQ·April 21, 2008
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. 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. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide 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, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016