Upper Arm Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Extracorporeal Shock Wave Lithotripter (U200)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Motif Aura Glow breast pump (Model Motif Aura Glow)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vericor Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Wearable breast pump (model W8)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

Powered Insertion System For A Cochlear Implant Electrode Array

FDA classification

FDA Class 2 ·Powered Insertion System For A Cochlear Implant Electrode Array

Ophthalmic Needle

FDA classification

FDA Class 2 ·Ophthalmic Needle

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 TEST

Non-Coring (Huber) Needle

FDA classification

FDA Class 2 ·Non-Coring (Huber) Needle

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement

FDA 510(k)

FDA Class 2 ·Orthopedic

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)

FDA 510(k)

FDA Class 2 ·General Hospital

C50 and C80 Multi-parameter Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)

FDA 510(k)

FDA Class 2 ·Radiology