Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADX CANNABINOIDS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADX TM BENZODIAZEPINES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADX AMPHETAMINE/METHAMPHEAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADX COCAINE METABOLITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADX TM BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AD X(TM) ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IDECAP DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASTar BC G- Kit and ASTar Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

FDA 510(k)

FDA Class 2 ·Radiology

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

QHRV 1 - HEALTH ASSESSMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

FDA 510(k)

FDA Class 2 ·Radiology

DiviTum TKa

FDA 510(k)

FDA Class 2 ·Immunology