LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated

FDA 510(k)

FDA Class 2 ·Orthopedic

ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

FDA 510(k)

FDA Class 2 ·Dental

P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS

FDA 510(k)

FDA Class 2 ·Dental

ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.

FDA 510(k)

FDA Class 2 ·Physical Medicine

AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

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

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) 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 HCV

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

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

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 VERSION 2.0, COBAS TAQMAN HCV TEST VERSION 2.0 FOR USE WITH 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 ·BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)

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

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA 3.0 ASSAY (BDNA)

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0

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