23 results · 17ms · 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.

Filters Fda510k ×

Materialise PKA Guide System

FDA 510(k)
FDA Class 2 ·Orthopedic

Materialise PKA Guide System

FDA 510(k)
FDA Class 2 ·Orthopedic

Materialise PKA Guide System

FDA 510(k)
FDA Class 2 ·Orthopedic

Partial Knee Application (PKA)

FDA 510(k)
FDA Class 2 ·Neurology

RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

T1040 AKA AURAWAVE

FDA 510(k)
FDA Class 2 ·Neurology

RESTORE (AKA RE/STOR)

FDA 510(k)
FDA Class 1 ·Gastroenterology, Urology

MULTI-PRIME AKA/MONO-PRIME

FDA 510(k)
FDA Class 2 ·Dental

PARA CHECK (AKA EIGHT CHECK-C)

FDA 510(k)
FDA Class 2 ·Hematology

THE CANAL (C.I.C.) AKA/HIDDEN EAR

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

FDA 510(k)
FDA Class 2 ·Orthopedic

BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)

FDA 510(k)
FDA Class 2 ·Radiology

CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

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

Inspire ICE aka Inspire ICE Clear Brackets

FDA 510(k)
FDA Class 2 ·Dental

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

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

INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)

FDA 510(k)
FDA Class 2 ·Anesthesiology

COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)
FDA Class 2 ·Neurology

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A

FDA 510(k)
FDA Class 2 ·Radiology