510(k) Device Clearances

PAL Sterilization Case

Microaire Surgical Instruments, LLC

Dermatological diode laser system

Beijing Stelle Laser Technology Co., Ltd.

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

Encompass Industries Sdn. Bhd.

G4Derm / G4Derm Plus Synthetic Wound Matrix

Gel4med, Inc.

Exceed™ Biplanar Expandable Interbody System

Spine Wave, Inc.

iQ 2 Nasal Mask, Phantom 2 Nasal Mask

Sleepnet Corporation

Freedom® Medial Congruent Liner

Maxx Orthopedics, Inc.

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

Xstrahl, Ltd.

RELIEEV Uterine Manipulator Injector (CUMI 5.0)

Li Medical Corporation , Ltd.

Angiography Injector

Shandong Int Medical Instruments Co., Ltd.

LW Retraction Cap

Ossvis Co., Ltd.

OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet N

Asahi Polyslider Co., Ltd.

TargetCool

Recensmedical, Inc.

TrueBalance™ Surgical System

These Three Medical, LLC

Gradual Dental Zirconia Blank

Liaoning Upcera Co., Ltd.

Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG);

Unimed Medical Supplies, Inc.

TeraRecon Cardiac.Chambers.MR (1.0.0)

Terarecon,Inc.

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM

Health & Life Co., Ltd.

Electric Wheelchair (KR8803)

Zhejiang Kairui Medical Device Co., Ltd.

Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocesse

Surgical Instrument Service and Savings Inc.(Dba Medline Ren

Disposable Medical Safety Hypodermic Needle

Hantech Medical Device Co., Ltd.

Electrically powered wheelchair (HP202)

Kunshan Hi-Fortune Health Products Co., Ltd.

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

Guangzhou Longest Medical Technology Co., Ltd.

HDH Treatment Planning System

Cdb Corporation

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

PrevisEA Device

Entac Medical, Inc.

Okamoto 002 Lubricated Polyurethane Male Condom

Okamoto USA, Inc.

Balanced Knee® System TriMax PS Plus Tibial Insert

Ortho Development Corporation

Enhanced AURORA™ Medical Diode System, and related accessories

Psoria-Shield, Inc.