5,571 results · 52ms · Sources: EU EUDAMED, US FDA

ManoScan System

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

Sterile Lancets for Single Use

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

Digital TENS Unit

FDA 510(k)
FDA Class 2 ·Neurology

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);

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

UC-CARE NaviGo Workstation

FDA 510(k)
FDA Class 2 ·Radiology

Medical surgical mask

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

Phyziofit Medical Surgical Mask

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

Cytomegalovirus (Cmv) Dna Quantitative Assay

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

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas® CMV

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

FDA 510(k)
FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·ACS OTW SOLARIS CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE

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

FDA Pre-Market Approval
FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System

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

FDA Pre-Market Approval
FDA Class 2 ·cobas HCV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CORONARY FLEXTOME CUTTING BALLOON