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