PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

FDA 510(k)

FDA Class 2 ·Neurology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRANSPORTABLE MODEL STS-T LITHOTRIPTER

DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)

FDA 510(k)

FDA Class 2 ·General Hospital

Ear Thermometer, Model ET005, ET008, ET009

FDA 510(k)

FDA Class 2 ·General Hospital

Disposable Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask (HNFM0304)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask (HNFM0103)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ear Thermometer, Model ET001

FDA 510(k)

FDA Class 2 ·General Hospital

Infrared Thermometer Model MD-H30

FDA 510(k)

FDA Class 2 ·General Hospital

Digital Thermometer, Model: DT007, DT008

FDA 510(k)

FDA Class 2 ·General Hospital

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digital thermometer, Model DT101, DT102

FDA 510(k)

FDA Class 2 ·General Hospital

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

FDA 510(k)

FDA Class 2 ·General Hospital

Digital Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FEMON Banana Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery