714 results · 26ms · Sources: EU EUDAMED, US FDA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER

FDA 510(k)
FDA Class 2 ·Dental

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

H500 Multi-Sensing Oximetry System

FDA 510(k)
FDA Class 2 ·Cardiovascular

OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Reprocessed Halo XP Diagnostic Electrophysiology Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

LAKE REGION MANUFACTURING GUIDEWIRES

FDA 510(k)
FDA Class 2 ·Cardiovascular

HYDROPHILIC COATED GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

OLYMPUS BF TYPE UC160-OL8

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Dental

Model X-100C CO-Met™ Oximetry System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)

FDA 510(k)
FDA Class 2 ·Cardiovascular

OLYMPUS STERILIZATION TRAYS

FDA 510(k)
FDA Class 2 ·General Hospital

GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Reprocessed Agilis NxT Steerable Introducer

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat