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
13225–13248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2022
Stainless Turbine
K203791 · EFB
Nakanishi, Inc.
Dental · 540d
Cleared Jun 21, 2022
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · MTD
Acutus Medical, Inc.
Cardiovascular · 463d
Cleared Jun 21, 2022
CORE-Trocar
K211148 · GCJ
Incore Co., Ltd.
General & Plastic Surgery · 428d
Cleared Jun 21, 2022
Lumenis Y&R Laser System
K211979 · GEX
Lumenis, Inc.
General & Plastic Surgery · 361d
Cleared Jun 21, 2022
Revaree Plus Vaginal Suppositories
K213220 · NUC
Farma-Derma S.R.L.
Obstetrics & Gynecology · 265d
Cleared Jun 21, 2022
Syngo Carbon Space VA20A
K213665 · LLZ
Siemens Healthcare GmbH
Radiology · 211d
Cleared Jun 21, 2022
Aspirex Thrombectomy System
K220270 · QEW
C.R. Bard, Inc.
Cardiovascular · 141d
Cleared Jun 21, 2022
NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0...
K220478 · MAX
Nu Vasive, Incorporated
Orthopedic · 123d
Cleared Jun 21, 2022
Sherlock
K220482 · NHA
Open Implants, LLC
Dental · 123d
Cleared Jun 21, 2022
Venue Go
K220800 · IYN
GE Medical Systems Ultrasound and...
Radiology · 95d
Cleared Jun 21, 2022
Vial Adapter Ø13mm
K220856 · LHI
Avenir Performance Europ?enne Medical...
General Hospital · 90d
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