XLTEK LED GOGGLES, MODEL LED-01

FDA 510(k)

FDA Class 2 ·Neurology

Hoffmann LRF System

FDA 510(k)

FDA Class 2 ·Orthopedic

OsteoCool V-2 RF Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ROSA® Knee System

FDA 510(k)

FDA Class 2 ·Neurology

Synthes Graphic Case & Tray System

FDA 510(k)

FDA Class 2 ·General Hospital

PRIMED Surgical Masks and PRIMED Procedure Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CONDUIT Lateral Switch Plate

FDA 510(k)

FDA Class 2 ·Orthopedic

Straumann Modular Cassette

FDA 510(k)

FDA Class 2 ·General Hospital

BÜHLMANN fCAL® turbo and CALEX® Cap

FDA 510(k)

FDA Class 2 ·Immunology

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIPER PRIME navigated inserter

FDA 510(k)

FDA Class 2 ·Neurology

TLX SRAs and TLX Gold Abutments

FDA 510(k)

FDA Class 2 ·Dental

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

FDA 510(k)

FDA Class 2 ·General Hospital

EPOC BLOOD ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRYOcheck FVIII Inhibitor Kit

FDA 510(k)

FDA Class 2 ·Hematology

SPECTROLYSE/PL PAI KIT

FDA 510(k)

FDA Class 2 ·Hematology

X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System

FDA 510(k)

FDA Class 2 ·Orthopedic

Collagentex Rx-6

FDA 510(k)

FDA Class 2 ·Physical Medicine

Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray

FDA 510(k)

FDA Class 2 ·Neurology

MEA110

FDA 510(k)

FDA Class 2 ·Neurology