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

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HASTING FINGER FIXATOR INSTRUMENTS

FDA 510(k)
FDA Class 1 ·Orthopedic

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074456393·INSTRUMENT 8880046 MAS HEIGHT ADJUSTER

Brigade

FDA UDI
Nuvasive, Inc.·00887517162267·Brigade® Plate, 46mm Lordotic

Arthrex®

FDA UDI
ARTHREX, INC.·00888867385801·Bending Pliers, Angled, Right

ULTRASPHYG BLOOD PRESSURE OPTION

FDA 510(k)
FDA Class 2 ·Cardiovascular

Masimo Rad-97 and Accessories

FDA 510(k)
FDA Class 2 ·Cardiovascular

RD SET YI

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

RD SET DCI

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023

HEARTSINE SAMARITAN 300P AND PAD PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·October 13, 2010

ORTHO SUMMIT SAMPLE HANDLING SYSTEM

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code MMH·December 19, 2012

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

MLRY-HD RNGLC SHL 48MM/L22

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code LZO·January 25, 2018

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