10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SNAP MODEL 6
FDA 510(k)
FDA Class 2
·Anesthesiology
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2024
GEMSTAR PAIN MGE SNG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 8, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·November 10, 2010
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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