19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AmeriWater MediQA Reverse Osmosis System (MSP3HF)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELMED
FDA UDI
ELMED INCORPORATED·00842180161276·5MM 36CM, MONOPOLAR SPATULA ELECTRODE, SIKE MOU...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776155803·5MM 45CM INSULATED BALL ELECTRODE, SIDE MOUNT R...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613109479·Monopolar Spatula Electrode, 5mm x 360mm, Side ...
Biomet® Cemented Cup Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868343438·
BIOMET CEMENTED CUP HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304449572·
MIZUHO AMERICA, INC.
FDA registration
MIZUHO AMERICA, INC.·13 products·🇺🇸 United States
SICKLE-CHEX SOLUBILITY KIT
FDA 510(k)
FDA Class 2
·Hematology
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·October 31, 2014
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 25, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 10, 2013
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 17, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 15, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026