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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