68 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)

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

Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

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.

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(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.

FDA classification
FDA Class 2 ·Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.

Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

FDA classification
FDA Class 2 ·Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

Dental Image Analyzer, In-Office

FDA classification
FDA Class 2 ·Dental Image Analyzer, In-Office

Blood, Occult, Colorimetric, In Urine

FDA classification
FDA Class 2 ·Blood, Occult, Colorimetric, In Urine

Test, Residual, Wbc In Leukoreduced Blood

FDA classification
FDA Class 2 ·Test, Residual, Wbc In Leukoreduced Blood

Check Valve, Retrograde Flow (In-Line)

FDA classification
FDA Class 2 ·Check Valve, Retrograde Flow (In-Line)

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification
FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

In Situ Polymerizing Peripheral Nerve Cap

FDA classification
FDA Class 2 ·In Situ Polymerizing Peripheral Nerve Cap

System, In-Office Tinting, Contact Lenses

FDA classification
FDA Class 2 ·System, In-Office Tinting, Contact Lenses

Blood, Occult, Enzymatic Method, In Urine

FDA classification
FDA Class 2 ·Blood, Occult, Enzymatic Method, In Urine

Galectin-3 In Vitro Diagnostic Assay

FDA classification
FDA Class 2 ·Galectin-3 In Vitro Diagnostic Assay

Heparin Flush In 0.45% Sodium Chloride

FDA classification
FDA Class 2 ·Heparin Flush In 0.45% Sodium Chloride

Laser, Microsurgical Argon, For Use In Otology

FDA classification
FDA Class 2 ·Laser, Microsurgical Argon, For Use In Otology