FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2023–2023 ×
3,347 results
3289–3312 of 3,347
Search insights Median review: 139d Cleared: 99% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Orthopedic
Cleared Jan 12, 2023
AIBOLIT 3D+
K222458 · LLZ
Aibolit Technologies, LLC
Radiology · 150d
Cleared Jan 12, 2023
PreXion3D Expedition
K222150 · OAS
Prexion Corporation
Radiology · 176d
Cleared Jan 12, 2023
HandX Instrument - Monopolar Spatula
K222011 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 189d
Cleared Jan 12, 2023
NeoGen PSR System
K221873 · GEI
Energist Limited
General & Plastic Surgery · 198d
Cleared Jan 12, 2023
Garmin ECG App
K221774 · QDA
Garmin International, Inc.
Cardiovascular · 205d
Cleared Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · QBJ
Dexcom, Inc.
Chemistry · 12d
Cleared Jan 11, 2023
INFINITY OCT System
K223764 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Jan 11, 2023
Alpha Control Liner System (ACLS)
K223738 · GXY
Coapt
Neurology · 28d
Cleared Jan 11, 2023
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
K223719 · KWQ
Aegis Spine, Inc.
Orthopedic · 30d
Cleared Jan 11, 2023
RadianceTx Radionuclide Brachytherapy Source
K223465 · KXK
Radiance Therapeutics, Inc.
Radiology · 55d
Cleared Jan 11, 2023
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
K223295 · FDA
Fujifilm Corporaton
Gastroenterology & Urology · 77d
Cleared Jan 11, 2023
NuVasive Reline System
K223181 · NKB
Nu Vasive, Incorporated
Orthopedic · 92d
Cleared Jan 11, 2023
Artix BG
K223000 · QEW
Inari Medical
Cardiovascular · 105d
Cleared Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl...
K222181 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 173d
Cleared Jan 11, 2023
Transducer Probe Cover
K221278 · ITX
Hony Medical Co., Ltd.
Radiology · 253d
Cleared Jan 11, 2023
DD Solid Connect® CAD/CAM Abutments
K191111 · NHA
Dental Direkt GmbH
Dental · 1356d
Cleared Jan 10, 2023
Haymaker® Screw System
K222799 · HWC
Orthocircle Spine D.B.A. OC Medical...
Orthopedic · 116d
Cleared Jan 10, 2023
ISAAC Neurovascular Navigation Catheter
K222115 · DQY
MicroVention, Inc.
Neurology · 176d
Cleared Jan 10, 2023
Metal Cannulated Screw
K221090 · HWC
Double Medical Technology, Inc.
Orthopedic · 272d
Cleared Jan 10, 2023
CoCr Head
K211047 · LPH
Zimmer GmbH
Orthopedic · 642d
Cleared Jan 09, 2023
21HQ513D
K223789 · PGY
Lg Electronics.Inc
Radiology · 21d
Cleared Jan 09, 2023
Vitrea Software Package, VSTP-002A
K223336 · LLZ
Canon Medical Systems Corporation
Radiology · 69d
Cleared Jan 09, 2023
VADER® Pedicle System, G21 Cement
K222789 · PML
Icotec AG
Orthopedic · 116d
Cleared Jan 09, 2023
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B,...
K222787 · IYO
Chongqing Sunkingdom Medical...
Radiology · 116d