1,369 results · 25ms · Sources: EU EUDAMED, US FDA

OGmend Implant System

FDA 510(k)
FDA Class 2 ·Orthopedic

Screw Sleeve Bone Fixation Device

FDA classification
FDA Class 2 ·Screw Sleeve Bone Fixation Device

AUTONEB ACCESSORY CROSS (AAC)

FDA 510(k)
FDA Class 2 ·Anesthesiology

Vertex Hip Fracture Nailing System

FDA 510(k)
FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

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

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

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

SENSUA!

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

AWARE PAD

FDA 510(k)
FDA Class 2 ·Radiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

FDA 510(k)
FDA Class 2 ·Dental

EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

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

LASER SYSTEM YELLOWSTAR

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

Dynamika

FDA 510(k)
FDA Class 2 ·Radiology

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

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

MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED

FDA 510(k)
FDA Class 2 ·Cardiovascular

DENSICOMP 250

FDA 510(k)
FDA Class 2 ·Radiology

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

FDA 510(k)
FDA Class 2 ·Cardiovascular