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