10 results · 22ms · Sources: EU EUDAMED, US FDA

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DEMISTIFIER ISOLATION CHAMBER

FDA 510(k)
FDA Class 2 ·Anesthesiology

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM

Elite®

FDA UDI
Ortho Organizers, Inc.·00190707052027·.022 L6R STD/NC -20T 5 OFF

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF

FDA 510(k)
FDA Class 2 ·Cardiovascular

BLUE SAIL INNOVATION

FDA 510(k)
FDA Class 1 ·General Hospital

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014

PROMUS ELEMENT ¿ LONG

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 8, 2013

UNKNOWN DEPUY ASR HIP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 15, 2010

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