18 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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D.N.E. External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
BONE SCREW, CORTICAL
FDA UDI
Biomet Orthopedics, LLC·00887868004780·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100257·CHU ASPIRATING SPECULUM SOLID
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837089047·
Canaveral®
FDA UDI
FLOSPINE LLC·B183115150800·Reduction Monoaxial Screw, 10.5mm x 80mm
VP SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
NEV'S INK AUTOCLAVE TAPES
FDA 510(k)
FDA Class 2
·General Hospital
PHILIPS CPAP DEVICE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 8, 2024
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
ECHELON ENDOPATH
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 30, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class II
·Terminated·B Braun Medical, Inc.·September 18, 2013