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OPTI-MOL FILTERED PUNCTURE PIN

FDA 510(k)
FDA Class 2 ·Anesthesiology

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·February 2, 2024

CREATININE PLUS VER.2

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JFY·March 18, 2026

COBAS C 503 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 8, 2026

CREATININE PLUS VER.2

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JFY·September 24, 2025

1823260-2015-04541

FDA Adverse Event
Malfunction ·November 13, 2015

COBAS 8000 COBAS C 701 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 19, 2025

COBAS C 501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 24, 2022

CREATININE PLUS VER.2

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JFY·March 13, 2026

Molar Matrix

FDA UDI
SONENDO, INC.·00858395006011·The Molar Matrix is used to form a flat surface...

Sealing Cap (Size 5)

FDA UDI
SONENDO, INC.·00858395006370·Sealing Caps attach to the Molar Procedure Inst...

Sealing Cap (Size 5)

FDA UDI
SONENDO, INC.·10858395006476·Sealing Caps attach to the Molar Procedure Inst...

Depth Gauges

FDA UDI
SONENDO, INC.·00858395006028·Used to gauge the depth of the pulp chamber. De...

Molar Matrix

FDA UDI
SONENDO, INC.·00858395006448·The Molar Matrix is used to form a flat surface...

Sealing Cap (Size 6)

FDA UDI
SONENDO, INC.·10858395006483·Sealing Caps attach to the Molar Procedure Inst...

Sealing Cap (Size 8)

FDA UDI
SONENDO, INC.·00858395006066·Sealing Caps attach to the Molar Procedure Inst...

Sealing Cap (Size 8)

FDA UDI
SONENDO, INC.·10858395006506·Sealing Caps attach to the Molar Procedure Inst...

Molar Procedure Instrument with Accessories

FDA UDI
SONENDO, INC.·00858395006189·The Molar Procedure Instrument, when used with ...

Sealing Cap (Size 6)

FDA UDI
SONENDO, INC.·00858395006387·Sealing Caps attach to the Molar Procedure Inst...

Sealing Cap (Size 10)

FDA UDI
SONENDO, INC.·00858395006424·Sealing Caps attach to the Molar Procedure Inst...