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
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
SurGenTec, LLC
Klassic Infection Spacer System
Total Joint Orthopedics, Inc.
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Remex Medical Corporation
CoreLevee
Lutronic Corporation
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
Dolanvy (Suzhou) Medical Technology Co., Ltd.
aprevo® anterior lumbar interbody fusion device with interfixation
Carlsmed, Inc.
LAIA XR
Augmented Reality Software S.L.
CEPHX3D
Orca Dental AI , Ltd.
DESS Dental Smart Solutions
Terrats Medical SL
THERMOCLICK
T&R BIOFAB CO., Ltd.
Ultiri Measurement System
ABBOTT MEDICAL
EasyOne Sky Spirometer
Ndd Medizintechnik AG
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
Tianjin Huahong Technology Co., Ltd.
Extremity Staple
Restor3D
Access TPO Antibody
Beckman Coulter, Inc.
INNOVISION-EXII
Dk Medical System
CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
Argon Medical Devices, Inc.
Stable-L Standalone Lumbar Interbody System
Nexus Spine, LLC
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI
Medline Industries, Inc.
Sil-Flow
Dsi Dental Solutions, Ltd.
brAIn Shoulder Positioning
Avatar Medical
TENSOR® Suture Button System
Globus Medical, Inc.
Eonis SCID-SMA kit
Perkinelmer, Inc.
FOX 810, FOX 980
A.R.C Laser GmbH
Sperm Freezing Medium
Gimbo Medical Technology Shenzhen Co., Ltd.
Albumin BCP2
Abbott Ireland Diagnostics Division
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
Philips Medical Systems Nederland B.V.
Clevaligner Software (V1.0.0)
Clevaligner, Ltd.
EnteraLoc Flow
Vonco Products
Nobel Biocare S Series Implants
Nobel Biocare AB
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