FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
15073–15096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 21, 2022
ParaMotion
K203761 · IPL
Powerbasetec GmbH
Physical Medicine · 394d
Cleared Jan 21, 2022
Infrared Thermometer
K211752 · FLL
Beijing Choice Electronic Technology...
General Hospital · 228d
Cleared Jan 21, 2022
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211864 · LZA
Siyang Jaysun Medtech Co., Ltd.
General Hospital · 219d
Cleared Jan 21, 2022
OSSIOfiber® Staple
K212594 · MNU
OSSIO , Ltd.
Orthopedic · 158d
Cleared Jan 21, 2022
Osteorevive
K212991 · MQV
Bone Solutions, Inc.
Orthopedic · 123d
Cleared Jan 21, 2022
Nitrile Examination Gloves
K213044 · LZA
Jiangsu Huayuan Medical Technology...
General Hospital · 121d
Cleared Jan 21, 2022
Saremco Print CROWNTEC
K213343 · EBF
Saremco Dental AG
Dental · 106d
Cleared Jan 21, 2022
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
K213412 · JOJ
Steris Corparation
General Hospital · 94d