FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
9241–9264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2023
Non absorbable Surgical Polypropylene Suture
K230746 · GAW
Shandong Haidike Medical Products...
General & Plastic Surgery · 181d
Cleared Sep 14, 2023
TEA Device
K230526 · QHH
Transtimulation Research, Inc.
Gastroenterology & Urology · 199d
Cleared Sep 14, 2023
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7,...
K230237 · MQC
Hkable 3D Biologic Printing...
Dental · 227d
Cleared Sep 14, 2023
BACK 4
K230167 · IPF
Swims America Corp
Physical Medicine · 237d
Cleared Sep 14, 2023
Straumann® BLC and TLC Implants
K230108 · DZE
Institut Straumann AG
Dental · 244d
Cleared Sep 14, 2023
HOPKINS Telescopes
K223885 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 261d
Cleared Sep 14, 2023
ChoiceSpine Blackhawk Ti Cervical Spacer System
K223869 · OVE
Choice Spine, LLC
Orthopedic · 265d
Cleared Sep 14, 2023
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
K223833 · PHX
Exactech, Inc.
Orthopedic · 266d
Cleared Sep 14, 2023
NEUROShield
K220034 · LLZ
In-Med Prognostics L3c
Radiology · 617d
Cleared Sep 13, 2023
AMSCO 600 Steam Sterilizer
K232485 · FLE
Steris
General Hospital · 28d
Cleared Sep 13, 2023
GenX-CR
K232158 · MUH
Genoray Co., Ltd.
Radiology · 55d
Cleared Sep 13, 2023
OSSIOfiber® Cannulated Trimmable Fixation Nail
K230750 · HTY
OSSIO , Ltd.
Orthopedic · 180d
Cleared Sep 13, 2023
Ultimate rTMS
K230735 · OBP
Brain Ultimate, Inc.
Neurology · 181d
Cleared Sep 13, 2023
NG Delivery Catheter
K230609 · QJP
Balt USA, LLC
Neurology · 191d
Cleared Sep 13, 2023
Lung-CAD
K223811 · MYN
Imagen Technologies, Inc.
Radiology · 267d
Cleared Sep 13, 2023
CRYOcheck Factor VIII Deficient Plasma with VWF
K222831 · GJT
Precision Biologic, Inc.
Hematology · 359d
Cleared Sep 13, 2023
AlloMap Heart Molecular Expression Testing
K221640 · OJQ
Caredx, Inc.
Chemistry · 464d
Cleared Sep 12, 2023
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K232526 · JAA
Canon Medical Systems Corporation
Radiology · 22d
Cleared Sep 12, 2023
Velacur
K232459 · IYO
Sonic Incytes
Radiology · 28d
Cleared Sep 12, 2023
Definium Pace Select
K231892 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 76d
Cleared Sep 12, 2023
Skyway Anterior Cervical Plate System
K231766 · KWQ
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 88d
Cleared Sep 12, 2023
Cartesion Prime (PCD-1000A/3) V10.15
K231748 · KPS
Canon Medical Systems Corporation
Radiology · 89d
Cleared Sep 12, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
K231317 · IYE
Varian Medical Systems, Inc.
Radiology · 127d
Cleared Sep 12, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K231112 · QHE
Materialise NV
Orthopedic · 146d