13 results · 23ms · Sources: EU EUDAMED, 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