POREX(TM) EAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANAL WALL PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ePTFE-Coated Auricular Implant

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Prosthesis, Ear, Internal

FDA classification

FDA Class 2 ·Prosthesis, Ear, Internal

F3D Corpectomy System

FDA 510(k)

FDA Class 2 ·Orthopedic

F3D Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CoreLink F3D™ Lateral System

FDA 510(k)

FDA Class 2 ·Orthopedic

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

FDA 510(k)

FDA Class 2 ·Cardiovascular

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

FDA 510(k)

FDA Class 2 ·Cardiovascular

F3D-C2 Cervical Stand-Alone System

FDA 510(k)

FDA Class 2 ·Orthopedic

F3D Cervical Stand-Alone Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)

FDA 510(k)

FDA Class 2 ·Dental

Osteo3 ZP Putty

FDA 510(k)

FDA Class 2 ·Orthopedic

MD-2300S Ultrasonic A/B Scanner for Ophthalmology

FDA 510(k)

FDA Class 2 ·Radiology

MD-6000P Bladder Scanner

FDA 510(k)

FDA Class 2 ·Radiology