QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EPI-C PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM

FDA 510(k)

FDA Class 2 ·Dental

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wrist Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

Red-Cell Count By Photometry

FDA classification

FDA Class 2 ·Red-Cell Count By Photometry

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

Rinse, Oral, Antibacterial (By Physical Means)

FDA classification

FDA Class 2 ·Rinse, Oral, Antibacterial (By Physical Means)

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

FDA classification

FDA Class 2 ·Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

FDA classification

FDA Class 2 ·Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA classification

FDA Class 2 ·Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification

FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

FDA classification

FDA Class 2 ·N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification

FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay