18 results · 27ms · Sources: EU EUDAMED, 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