510(k) Device Clearances

The Alma Hybrid Laser System

Alma Lasers, Inc.

S.I.N. Dental Implant System

S.I.N. - Sistema DE Implante Nacional S.A.

FilteredFlo Warming Blankets

Iob Medical, Inc.

Insufflation Retention Device (IRD) (11173-325-101)

BPEndo, LLC

VEOFIX Snap Off Screw

Steps Ortho

Merit Syringe

Merit Medical Systems, Inc.

LUXEN 5G

Dentalmax Co., Ltd.

LGO-Surgical Laser Fibers

Light Guide Optics International , Ltd.

Rayvolve

Azmed Sas

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display S

Medimaging Integrated Solution, Inc (Miis)

Dexter L6 System

Distalmotion SA

C.C. LIFE 21

21 Equipment S.R.L.

MasterX 800 Series

Medicatech USA

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

Pro Med Instruments GmbH

InstaTRU Instant Biological Indicator for Steam (IBI-05)

True Indicating, LLC

Precise Image

Philips Medical Systems Nederland B.V.

TrueLok Elevate

Orthofix Srl

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)

Sunglor Technology Co., Ltd.

FSYX Ocular Pressure Adjusting Pump

Balance Ophthalmics, Inc.

Legend X Desktop System

Pollogen, Ltd.

Pounce Thrombectomy System

Surmodics,Inc.

Anchor with Fiber Wire and Disposable Inserter

Ortobio S.A.

Surgikor Fixation One, Abutment Blanks and Abutments

Surgikor, LLC

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconaz

bioMerieux, Inc.

AURORA Evacuator +Coag

Rebound Therapeutics

FG Bone Graft M

Full Golden Biotech Co., Ltd.

Ascend VBR System, Ascend NanoTec VBR System

Alphatec Spine, Inc.

REUNION Sacroiliac Joint Fusion System

Astura Medical

AB1 Electrosurgical Instrument, Creo Electrosurgical System

Creo Medical, Ltd.

CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electro

Pulse Biosciences, Inc.