ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

FDA 510(k)

FDA Class 2 ·Immunology

ViVi® Toga Premium

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Codman Electrosurgical Generator, Foot Pedal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

H-I-M-TEST FOR DETECTING HUMAN CHOR. GON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

FDA 510(k)

FDA Class 2 ·Orthopedic

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y

FDA 510(k)

FDA Class 2 ·General Hospital

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSMART

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIO SERV

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE

FDA 510(k)

FDA Class 2 ·Neurology

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System