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510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

iTero Lumina™ Pro

Align Technology , Ltd.

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl C

Kl-Kepong Rubber Products Sdn. Bhd.

Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer

Wenzhou Longwan Medical Device Factory

Electric Wheelchair (Model P2)

Superpi Robot Co., Ltd.

BD Vacutainer® Eclipse™ Blood Collection Needle

Becton, Dickinson and Company

Denudation Pipettes

Guangzhou Pinzhi Medical Device Co., Ltd.

Hair Removal Device (Model: IPL-D26, IPL-D19)

Shenzhen Desida Technology Co., Ltd.

NeuroSpan Bridge

Auxilium Biotechnologies, Inc.

DIANA

ROPCA ApS

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs,

Eco Medi Glove Sdn. Bhd.

MagnetOs Putty

Kuros Biosciences B.V

Gastric Alimetry

Alimetry , Ltd.

CerroZone Mini

Cerrozone, LLC

Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)

Zimmer, Inc.

Magicore System

Innobiosurg Co., Ltd.

Disposable Medical Mask

Guangzhou Fuzelong Hygiene Material Co., Ltd.

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)

Xingyu Medical Tech Co., Ltd.

EQ-M

Meta Systems Co., Ltd.

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

Casebioscience, Inc.

Multimodality Simulation Workspace (MM Sim) (v1.0.0)

Philips Medical Systems Nederland B.V.

X-Twist PEEK Suture Anchor

Parcus Medical, LLC

NGM WAVE PLIF Cage

NGMedical GmbH

Accuro 3S

Rivanna Medical, Inc.

Disposable Surgical Gown

Nanning Tecbod Biological Technology Co., Ltd.

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid a

Hartalega NGC Sdn. Bhd.

Remvia NightGuard

Remvia

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

Ushare Medical, Inc.

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture

ETHICON, Inc.

Agnes

Agnes Medical Co., Ltd.

Apex Locator

Cefla S.C.

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