Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Beauty LED Mask, Model: KFB265

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

5MP GRAYSCALE LCD DISPLAY

FDA 510(k)

FDA Class 2 ·Radiology

Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

FDA 510(k)

FDA Class 2 ·Neurology

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

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Endoscopic Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

7 TRICYCLIC ANTIDE PRESSANTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS TaqMan HCV Test, v2.0 for use on the High Pure System

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM

Light Based Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery