705 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.

O2-IN-A-BOX, O2-IN-A-BOX

FDA 510(k)
FDA Class 2 ·Anesthesiology

K-ASSAY C1-INA

FDA 510(k)
FDA Class 2 ·Immunology

LANCER L-INA ANTI-IGM

FDA 510(k)
FDA Class 2 ·Immunology

LANCER L-INA ANTI-C3

FDA 510(k)
FDA Class 2 ·Immunology

LANCER L-INA ANTI-IGA

FDA 510(k)
FDA Class 2 ·Immunology

LANCER L-INA ANTI-IGG

FDA 510(k)
FDA Class 2 ·Immunology

LANCER L-INA HUMAN REFERENCE SERUM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MCSCK838 CATHETER IN A TRAY (KIT)

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

MCSCK638 CATHETER IN A TRAY (KIT)

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

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant

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

NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY

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

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVA 5 NA/K/C1 ALALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVA 4 NA/K/C1/TCO2/LI ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·Alinity m HBV

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