13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517403520·CoRoent® XL, 12x18x60mm 10°
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981260·anteriors; shade C1; mould IM2
Sklar®
FDA UDI
SKLAR CORPORATION·10649111258909·DISSECT SCISS 15CM ROUND HANDL
Symmetry
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482087329·Symmetry® Grasper, Meah, Slide Lock Handle w/Ro...
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MiiS Horus Scope DPT 100
FDA 510(k)
FDA Class 2
·Ophthalmic
CPS ANCHOR PLUG 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 7, 2024
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·February 27, 2013
UNKNOWN
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JDI·February 2, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·August 5, 2014
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 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