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

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Antiserum, Digoxin

FDA classification
FDA Class 2 ·Antiserum, Digoxin

T1040 AKA AURAWAVE

FDA 510(k)
FDA Class 2 ·Neurology

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

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

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

FDA 510(k)
FDA Class 2 ·Cardiovascular

GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·Abbott RealTime HBV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Cobas AmpliPrep/Cobas TaqMan CMV Test