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POLAREX AND POLAREX MLD

FDA 510(k)
FDA Class 1 ·Ophthalmic

Siemens

FDA UDI
Ws Audiology Usa, Inc.·04056839062531·Siemens BTE SIRION 2 M LD BG Hearing Aid

INTERA 3000

FDA Adverse Event
Injury ·INTERA ONCOLOGY, INC·Product code LKK·May 16, 2024

COBAS INTEGRA 800

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 10, 2010

INTERA 3000

FDA Adverse Event
Malfunction ·INTERA ONCOLOGY, INC·Product code LKK·December 17, 2025

RLW,3LD,PINCH,MLD ML,29",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151788·RLW,3LD,PINCH,MLD ML,29",AHA

RLW,5LD,SNAP,MLD ML,51",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151825·RLW,5LD,SNAP,MLD ML,51",AHA

RLW,5LD,SNAP,MLD ML,MX,AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151832·RLW,5LD,SNAP,MLD ML,MX,AHA

RLW,5LD,PINCH,MLD ML,29",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151849·RLW,5LD,PINCH,MLD ML,29",AHA

LW NKN,6LEAD,MLD,PINCH,MX,AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828132640·LW NKN,6LEAD,MLD,PINCH,MX,AHA

LW NKN,6LEAD,MLD,PNCH, 29"AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828131155·LW NKN,6LEAD,MLD,PNCH, 29"AHA

RLW,5LD,SNAP,MLD ML,29",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151818·RLW,5LD,SNAP,MLD ML,29",AHA

RLW,5LD,PINCH,MLD ML,MX,AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151863·RLW,5LD,PINCH,MLD ML,MX,AHA

RLW,3LD,SNAP,MLD ML,29",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151764·RLW,3LD,SNAP,MLD ML,29",AHA

RLW,3LD,PINCH,MLD ML,51",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151795·RLW,3LD,PINCH,MLD ML,51",AHA

RLW,3LD,SRLCK,MLD ML,29",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151801·RLW,3LD,SRLCK,MLD ML,29",AHA

RLW,5LD,SRLCK,MLD ML,MX,AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151894·RLW,5LD,SRLCK,MLD ML,MX,AHA

LW MULTILINK,5LD,MLD,PINCH,29",INTERMED

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828140218·LW MULTILINK,5LD,MLD,PINCH,29",INTERMED

RLW,5LD,PINCH,MLD ML,51",AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828151856·RLW,5LD,PINCH,MLD ML,51",AHA

LW NKN,6LEAD,MLD,SURELOCK,MX,AHA

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828132657·LW NKN,6LEAD,MLD,SURELOCK,MX,AHA