19 results · 18ms · Sources: EU EUDAMED, US FDA

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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