DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE

FDA 510(k)

FDA Class 2 ·Anesthesiology

LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGICAL RETRACTORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LZI Hydrocodone 300 Semi-Quantitative Calibrator Set

FDA UDI

LIN-ZHI INTERNATIONAL, INC.·00850624008506·HYD 300 Low Calibrator 150 ng/mL (1 x 15 mL), ...

Novocol EXACTON SOFT CHRSD RELINE PWD/LIQ

FDA UDI

SEPTODONT, INC·07540187001474·

LZI Hydrocodone 100 Semi-Quantitative Calibrator Set

FDA UDI

LIN-ZHI INTERNATIONAL, INC.·00850624008445·HYD 100 Low Calibrator 50 ng/mL (1 x 15 mL) HYD...

Novocol EXACTON HARD CHRSD RELINE PWD/LIQ

FDA UDI

SEPTODONT, INC·07540187001450·

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval

FDA Class 3 ·remede® System

The Circadia C200 System

FDA registration

Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.·2 products·🇲🇾 Malaysia

Breath Sensors

FDA registration

NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)·2 products·🇨🇦 Canada

Salter Labs Sleep Diagnostic Cannulas, non DEHP

FDA registration

Salter Labs de Mexico de S.A. de C.V.·2 products·🇲🇽 Mexico

Salter Labs Sleep Diagnostic Cannulas, non DEHP

FDA registration

Salter Labs·2 products·🇺🇸 United States

MightySat Rx

FDA registration

Masimo Corporation·2 products·🇺🇸 United States

Wesper Lab

FDA registration

WESPER INC. LIC·2 products·🇺🇸 United States

Sleepiz

FDA registration

L-TEK D.O.O.·2 products·🇸🇮 Slovenia