CO2 Laser Therapy Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Promisemed X-Safety Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Unscented Menstrual Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIT BELT

FDA 510(k)

FDA Class 2 ·Physical Medicine

BIOEASY Multi-Drug Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Irradiation Cosmetic Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

FDA 510(k)

FDA Class 2 ·Orthopedic

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOP GLOVE VINYL EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DIASTAT ANTI-LA (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

Lockado Repositionable Hemostasis Clip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

LOCKING COMPRESSION PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

TENS and EMS Stimulation (OTC)

FDA 510(k)

FDA Class 2 ·Neurology

YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)

FDA 510(k)

FDA Class 1 ·Physical Medicine

ELECTRONIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital