19 results
·
20ms
·
Sources: EU EUDAMED, US FDA
VENTED NITROGLYCERIN I.V. SET
FDA 510(k)
FDA Class 2
·General Hospital
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780515487·CODMAN® Disposable Catheter Passer
CODMAN
FDA UDI
Cerenovus, Inc.·10886704040408·CODMAN Disposable Catheter Passer 36cm
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268215151·CUSTOM SURGICAL KIT VEIN PACK
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE CATH PASSER 36CM
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·December 11, 2025
DISPOSABLE CATH PASSER 36CM
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·July 19, 2024
DISPOSABLE CATH PASSER 36CM
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·June 18, 2025
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·March 27, 2014
UNKNOWN LEFT STRYKER TITANIUM/CERAMIC IMPLANT HIP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code KWB·October 24, 2012
SMARTSITE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·January 15, 2014
STRATA II SHUNT ASSEMBLY, SMALL, 90 CM
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·August 27, 2010
DISPOSABLE CATH PASSER 36CM
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·September 27, 2024
DISPOSABLE CATH PASSER 36CM
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·March 21, 2025
OEC UroView 2800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016
OEC 9800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
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