32 results · 23ms · Sources: EU EUDAMED, US FDA

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STELLARIS PC VISION ENHANCEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

STELLARIS VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

CoRoent

FDA UDI
Nuvasive, Inc.·00887517635532·CoRoent Ant TLIF PEEK, 10x11x32mm 15°

Preci-Sagix

FDA UDI
Preat Corporation·00842092108758·Preci-Sagix 1.7 Metal Housing

ILIZAROV SYSTEMS

FDA UDI
MEDICALPLASTIC SRL·08033201841310·5/8 RING INTERNAL DIAMETER 150MM SS

SleepWeaver Advance Pediatric - Mask & Headgear - Blue

FDA UDI
CIRCADIANCE, LLC·B036101325·SleepWeaver Advance Pediatric Cloth Nasal PAP M...

JOBST Bella Lite

FDA UDI
BSN MEDICAL, INC.·00035664013257·BELLA LITE 15-20 MM HG GAUNTLET SMALL BEIGE 1 E...

Life Instruments

FDA UDI
Life Instrument Corporation·M930710132500·Custom Curette Downpusher LG

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161013250·Sypert Bone Rongeur

FLO ASSISTANT, MODEL 4-250-00

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDIFIX URETEROSCOPE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SureLOK Mini Posterior Cervical/Upper Thoracic System

FDA UDI
PRECISION SPINE, INC.·00840019907484·25mm Open Offset

Latch Reamer

FDA UDI
BICON, LLC·00813110024299·2.5mm Extended Latch Reamer

UNKNOWN DEPUY ACETABULAR LINER

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 9, 2013

PHILOS D

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code DXY·September 19, 2014

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 24, 2011

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016

VITROS ECI IMMUNODIAGNOSTIC SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

FDA Enforcement
Class II ·Ongoing·DJO, LLC·May 20, 2026