15 results
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19ms
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Sources: EU EUDAMED, US FDA
XOMED-TREACE RIGID ROD LENS ENDOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094173·KM33-105
Brasseler USA
FDA UDI
Provision·00810041064851·
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 18.5 x 9 x 0.51mm
FDA UDI
SURETEK MEDICAL·B390KM331051·
Brasseler USA
FDA UDI
Provision·B504OMKM331050·
SeaSpine Spacer System - Pacifica™
FDA UDI
Seaspine Orthopedics Corporation·10889981058722·Pacifica Trial, 9mm x 20mm x 12mm
SeaSpine Spacer System - Pacifica™
FDA UDI
Seaspine Orthopedics Corporation·10889910058724·Pacifica Trial, 9mm x 20mm x 12mm
NA
FDA UDI
STERILMED, INC.·10888551016117·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
FDA 510(k)
FDA Class 2
·Microbiology
BREEZE NEBULIZER (NBR-10X)
FDA 510(k)
FDA Class 2
·Anesthesiology
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·January 29, 2013
30" TRANSPORT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·December 13, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.
FDA Enforcement
Class II
·Terminated·Cyberonics, Inc·August 23, 2017
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013