Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Axis-Shield Homocysteine Controls

FDA UDI

AXIS-SHIELD DIAGNOSTICS LIMITED·05055845400022·The Axis-Shield Homocysteine Control Kit is int...

Trinity Biotech

FDA UDI

CLARK LABORATORIES, INC.·05391516743938·Macra® Lp(a)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

Blood Collection Accessory (BUCA)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bevel Up Holder

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Blood Transfer Accessory (BTA)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SafetiCET Safety Lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SafetiHeel, MediHeel, Novaplus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE-M 2.0

AFCS PEARLS™ & SANDS™ Corner clamps

FDA UDI

Synergie Nederland B.V.·08720387388110·Air-Fluidized bed - see www.synergiecare.com A...

QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK

FDA 510(k)

FDA Class 1 ·Immunology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILITATION CARTHETERS

FDA Pre-Market Approval

DIASORIN ETI-CORE-IGMK PLUS ASSAY