28 results · 22ms · Sources: EU EUDAMED, 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