28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sniper Infusion Catheter with Balloon Occlusion
FDA 510(k)
FDA Class 2
·Cardiovascular
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277119780·Femur/Tibia Fracture Distractor Moveable Arm
Origin Coxa Vara Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215013141·
Paxeon Origin Coxa Vara Hip Stem
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200375·Origin Stem, Coxa Vara Size 9
Origin Hip Stem, Coxa Vara
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051839·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111809040·Coxa Vara Collared Stem, Size 9
FEEL-FINE INSULIN PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UniTip Catheter
FDA UDI
Unisensor AG·07640172972380·
STRATUS Stem
FDA UDI
AMPLITUDE SAS·03701089521420·
MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS
FDA Adverse Event
Injury
·MENICON CO., LTD.·Product code LPL·March 18, 2026
MENICON ASRB (ASMOFILCONA)
FDA Adverse Event
Injury
·MENICON CO., LTD.·Product code LPL·February 25, 2025
MENICON ASRB (ASMOFILCONA)
FDA Adverse Event
Injury
·MENICON CO., LTD.·Product code LPL·January 14, 2025
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·July 22, 2011
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 20, 2013
ACCU-CHEK COMPACT PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·September 24, 2008
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
FDA Enforcement
Class II
·Terminated·Theragenics Corporation·December 26, 2018
MICROPLASTY ANTERIOR STEM EXTRACTOR ADAPTE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LXH·April 10, 2018
MENICON ASRB (ASMOFILCONA)
FDA Adverse Event
Injury
·MENICON CO., LTD.·Product code LPL·May 20, 2024
MENICON ASRB (ASMOFILCONA)
FDA Adverse Event
Injury
·MENICON CO., LTD.·Product code LPL·October 25, 2023