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
InferRead Lung CT.AI
Infervision Medical Technology Co., Ltd.
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
Neuroelectrics Barcelona S.L.U.
ENFit enteral syringes (NUTRIFIT)
Pentaferte Italia S.R.L.
Denti.AI Detect
Denti.Ai Technology, Inc.
Apollo TMS Therapy System
Mag & More GmbH
InThrill Thrombectomy System
Inari Medical, Inc.
Eko Foundation Analysis Software with Transformers (EFAST)
Eko Health, Inc.
ArtiSential Laparoscopic Instruments-Electrodes
Livsmed, Inc.
Anthogyr Surgical Cassettes
Anthogyr
Catalyst F1x Shoulder System
Catalyst Orthoscience, Inc.
SofWave System
Sofwave Medical, Ltd.
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Haemonetics
EvoEndo Single-Use Endoscopy System
EvoEndo, Inc.
Stabilis SA Cervical Stand-Alone System (Various PNs)
Acuity Surgical Devices, LLC
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Canon Medical Systems Corporation
Surgical Isolation Cover Gown
Wuhan Dymex Healthcare Co., Ltd.
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Straumann® PURE Ceramic Implants
Institut Straumann AG
Annalise Enterprise CXR Triage Trauma
Annalise-Ai Pty , Ltd.
RI.KNEE Adjustable Tibia Cut Guide
Enztec Limited
Altus Spine Pedicle Screw System
Altus Partners, LLC
A8 INTEGR8 Porous Pedicle Screws
Allumin8, Inc.
EyeBOX (Model EBX-4)
Oculogica, Inc.
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
Wrp Asia Pacific Sdn. Bhd.
SPINEART Navigation Instrument System
Spineart SA
EdgeFlow UW20
Edgecare, Inc.
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
Depuy Ireland UC
JOULE 1064nm System and Accessories
Sciton, Inc
SiJoin®T3
Vgi Medical, Inc.
VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
Advin Biotech, Inc.
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