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
13201–13224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
K220494 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 121d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Smart Soft Healthcare AD
Radiology · 121d
Cleared Jun 23, 2022
bite away neo
K220514 · IRT
mibeTec GmbH
Physical Medicine · 121d
Cleared Jun 23, 2022
Mural Perinatal Surveillance
K220732 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 101d
Cleared Jun 23, 2022
Introcan Safety 2 IV Catheter
K220756 · FOZ
B.Braun Medical, Inc.
General Hospital · 100d
Cleared Jun 23, 2022
Ultrasound System SONIMAGE MX1
K220993 · IYN
Konica Minolta, Inc.
Radiology · 80d
Cleared Jun 23, 2022
ZEPTO Precision Capsulotomy System
K221188 · PUL
Centricity Vision, Inc.
Ophthalmic · 59d
Cleared Jun 23, 2022
Excipio SV Thrombectomy Device
K221204 · QEW
Contego Medical, Inc.
Cardiovascular · 58d
Cleared Jun 23, 2022
Axial3D Cloud Segmentation Service
K221511 · LLZ
Axial Medical Printing Limited
Radiology · 30d
Cleared Jun 22, 2022
Klassic Knee System
K211877 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 370d
Cleared Jun 22, 2022
Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711),...
K212665 · DQA
Huizhou Xiaoou Technology Co., Ltd.
Anesthesiology · 303d
Cleared Jun 22, 2022
T3 Platform Software
K213230 · PPW
Etiometry, Inc.
Cardiovascular · 266d
Cleared Jun 22, 2022
Qlicksmart BladeFlask UNIVERSAL
K213274 · MMK
Qlicksmart Pty , Ltd.
General Hospital · 265d
Cleared Jun 22, 2022
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283 · GBM
Convatec Limited
Gastroenterology & Urology · 264d
Cleared Jun 22, 2022
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced,...
K213345 · EWO
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jun 22, 2022
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
K213682 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 212d
Cleared Jun 22, 2022
Nitrile Examination Gloves
K213739 · LZA
Hangzhou Runheng Medical Co., Ltd.
General Hospital · 205d
Cleared Jun 22, 2022
Glidewell 3DP Denture Base Resin
K213765 · EBI
Prismatik Dentalcraft, Inc.
Dental · 203d
Cleared Jun 22, 2022
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K220413 · QPP
Canary Medical USA, LLC
Orthopedic · 128d
Cleared Jun 22, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex...
K220586 · FTL
Sofradim Production
General & Plastic Surgery · 113d
Cleared Jun 22, 2022
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
K221008 · MUH
Shanghai Handy Medical Equipment Co.,...
Radiology · 78d
Cleared Jun 22, 2022
TC Gloves
K221185 · LYY
Thanh Cong Pharmaceutical and Trading...
General Hospital · 58d
Cleared Jun 22, 2022
Disposable Nitrile Powder-Free Examination Gloves
K221192 · LZA
Shandong Maida Medical Technology...
General Hospital · 58d
Cleared Jun 22, 2022
Esophageal TTS Stent
K221482 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 30d