973 results · 27ms · Sources: EU EUDAMED, US FDA

CO2 Laser Therapy Systems (SHE-LSP003-1)

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

Electronic Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

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

Electric nasal aspirator (HTD2601US)

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER

Globalcare Blood Pressure Monitor (GUS610)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

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

OLYMPUS SUCTION PUMP MODEL KV-4

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

DermaSensor

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER

On-Body Injector

FDA classification
FDA Class 2 ·On-Body Injector

UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER