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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13969–13992 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2022
Merlin Aspiration System
K213771 · DXE
Mivi Neurovascular, Inc.
Cardiovascular · 56d
Cleared Jan 26, 2022
SternaFuse Fixation System
K202914 · HRS
Fusion Innovations, LLC
Orthopedic · 484d
Cleared Jan 26, 2022
American-Made Surgical Mask
K210101 · FXX
Armbrust, Inc.
General Hospital · 377d
Cleared Jan 26, 2022
LASSOSTAR NAV Circular Mapping Catheter
K211219 · DRF
Biosense Webster, Inc.
Cardiovascular · 278d
Cleared Jan 26, 2022
Surgical Face Mask
K212610 · FXX
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 162d
Cleared Jan 26, 2022
LightStim Elipsa
K212771 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 148d
Cleared Jan 26, 2022
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
K212868 · FAD
Rocamed Sam
Gastroenterology & Urology · 139d
Cleared Jan 26, 2022
Vitalograph Model 6000 Alpha
K212938 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 133d
Cleared Jan 26, 2022
ANTHEM® Fracture System
K213591 · HRS
Globus Medical, Inc.
Orthopedic · 75d
Cleared Jan 26, 2022
SmoothSkin Pure Mini
K213692 · OHT
Cyden Limited
General & Plastic Surgery · 64d
Cleared Jan 25, 2022
INNO SLA Submerged Implant System
K201323 · NHA
Cowellmedi Co., Ltd.
Dental · 617d
Cleared Jan 25, 2022
iCare HOME2
K211355 · HKY
Icare Finland OY
Ophthalmic · 267d
Cleared Jan 25, 2022
HDH Treatment Planning System
K212173 · PNN
Cdb Corporation
Dental · 197d
Cleared Jan 25, 2022
ADI Medical Surgical Face Mask
K213347 · FXX
Asia Dynamics Inc., D/B/A Adi Medical
General Hospital · 109d
Cleared Jan 24, 2022
Disposable Syringe with Needle
K211482 · FMF
Shandong Qinkai Medical Industry Co.,...
General Hospital · 257d
Cleared Jan 24, 2022
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
K212333 · IYN
Canon Medical Systems Corporation
Radiology · 181d
Cleared Jan 24, 2022
Revaclear 500, Revaclear 400, Revaclear 300
K213639 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 67d
Cleared Jan 24, 2022
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
K213780 · MQB
Canon, Inc.
Radiology · 53d
Cleared Jan 23, 2022
Thermoplastic Elastomer (TPE) Hybrid Examination Glove
K210463 · LZA
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 341d
Cleared Jan 23, 2022
Steiking Packaging for Medical Devices
K210810 · FRG
Wipak OY
General Hospital · 312d
Cleared Jan 23, 2022
Myflon Surgical Mask Level 3
K212111 · FXX
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 201d
Cleared Jan 23, 2022
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
K213970 · FXX
Danameco Medical Joint Stock Corporation
General Hospital · 34d
Cleared Jan 21, 2022
e-Throne Folding Wheelchair, Model: ET-12F22
K191105 · ITI
Golden Motor Technology Co., Ltd.
Physical Medicine · 1002d
Cleared Jan 21, 2022
Abbott Medical Grounding Pad, model RF-DGP-IS
K203293 · GXD
Abbott Medical
Neurology · 438d