9 results · 20ms · Sources: EU EUDAMED, US FDA

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GUAZE BALLS CAT.#601-720

FDA 510(k)
FDA Unclassified ·Unknown

Polishers

FDA UDI
DFS - DIAMON GmbH·04057176147394·UPORAL D flame, pu: 2 pcs

KAIYANG STEEL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

CAM-10 EXSUFFLATION BELT #11-001

FDA 510(k)
FDA Class 2 ·Anesthesiology

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 23, 2012

HEARTSINE SAMARITAN 300P AND PAD PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2015

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

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