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: Cleared only ×
174,955 results
12961–12984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2022
NeuroLine Disposable Cranial Perforator with Hudson end
K213228 · HBF
Emd Endoszkop Muszer Gyarto ES...
Neurology · 264d
Cleared Jun 17, 2022
Freeze’n Clear Skin Clinic Warts & Tags
K211099 · GEH
Cryoconcepts LP
General & Plastic Surgery · 430d
Cleared Jun 17, 2022
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
K212871 · OAB
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 281d
Cleared Jun 17, 2022
IDx-DR v2.3
K213037 · PIB
Digital Diagnostics, Inc.
Ophthalmic · 269d
Cleared Jun 17, 2022
MyOnyx System
K213197 · IPF
Thought Technology , Ltd.
Physical Medicine · 261d
Cleared Jun 17, 2022
CipherOx CRI Tablet
K213255 · PPW
Flashback Technologies, Inc.
Cardiovascular · 260d
Cleared Jun 17, 2022
Disposable Endoscopy Adapter Set
K220210 · ODC
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 142d
Cleared Jun 17, 2022
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220431 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 122d
Cleared Jun 17, 2022
restor3d TiDAL Lumbar Interbody Fusion Device
K220523 · MAX
Restor3d
Orthopedic · 114d
Cleared Jun 17, 2022
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
K220572 · JFB
Ceragem Co., Ltd.
Physical Medicine · 109d
Cleared Jun 17, 2022
ART-PLAN
K220813 · QKB
Therapanacea
Radiology · 88d
Cleared Jun 17, 2022
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
K221117 · IYN
Samsung Medison Co., Ltd.
Radiology · 60d
Cleared Jun 17, 2022
SPY Laparoscope
K221217 · GCJ
Stryker
General & Plastic Surgery · 51d
Cleared Jun 17, 2022
ARIA Radiation Therapy Management (v16.1 MR3)
K221408 · IYE
Varian Medical Systems, Inc.
Radiology · 32d
Cleared Jun 17, 2022
ElucidVivo A.3
K221463 · LLZ
Elucid Bioimaging, Inc.
Radiology · 29d
Cleared Jun 17, 2022
Baby Gorilla/Gorilla Plating System
K221465 · HRS
Paragon 28, Inc.
Orthopedic · 29d
Cleared Jun 17, 2022
Langston dual lumen catheter
K221470 · DQO
Vascular Solutions, LLC
Cardiovascular · 28d
Cleared Jun 16, 2022
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
K201037 · NBW
Taidoc Technology Corporation
Chemistry · 787d
Cleared Jun 16, 2022
DePuy 3D Additive TriFlange Acetabular Cup
K201348 · LPH
Depuy International, Ltd.
Orthopedic · 756d
Cleared Jun 16, 2022
Custom-made Invisible Aligners
K203624 · NXC
Zhejiang Yinchili Medical Technology...
Dental · 552d
Cleared Jun 16, 2022
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without...
K212426 · MQL
Donnevie Medical Technology...
Obstetrics & Gynecology · 316d
Cleared Jun 16, 2022
Seer Home
K212788 · GWQ
Seer Medical Pty, Ltd.
Neurology · 288d
Cleared Jun 16, 2022
TLC Unicompartmental Knee System
K212870 · HSX
Signature Orthopaedics Pty, Ltd.
Orthopedic · 280d
Cleared Jun 16, 2022
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea...
K213504 · JAK
Canon Medical Systems Corporation
Radiology · 227d