Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Gelfoam (absorbable gelatin) Sterile Sponge

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

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM ABSORBABLE GELATIN SPONGE

Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

FDA classification

FDA Not Classified ·Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

FDA classification

FDA Class 2 ·Voltage Gated Calcium Channel (Vgcc) Antibody Assay

GfM mbH

System producer

🇩🇪 Germany

LFB BIOMEDICAMENTS

System producer

🇫🇷 France

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

FDA classification

FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

pfm medical ag

Authorized representative

🇩🇪 Germany·3 Manufacturers

pfm medical gmbh

Authorized representative

🇩🇪 Germany·3 Manufacturers

Bathophenanthroline, Colorimetry, Iron (Non-Heme)

FDA classification

FDA Class 1 ·Bathophenanthroline, Colorimetry, Iron (Non-Heme)

Ige, Ferritin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Ferritin, Antigen, Antiserum, Control

pfm medical cpp

System producer

🇨🇭 Switzerland

Single-Use Reprocessed Ultrasonic Surgical Instruments

FDA classification

FDA Unclassified ·Single-Use Reprocessed Ultrasonic Surgical Instruments

C-01-1080-682-19

Certificate

MDD Annex II (excluding section 4)·LM-Instruments Oy·Eurofins Electric & Electronics Finland Oy·64 Basic UDI-DIs

C-01-1080-682-19

Certificate

MDD Annex II (excluding section 4)·LM-Instruments Oy·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

Arthrone Oy

Importer

🇫🇮 Finland·7 Manufacturers

SANGUESA SA

Importer

🇪🇸 Spain·10 Manufacturers