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
11905–11928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX...
K220465 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 272d
Cleared Nov 16, 2022
Endoscopy Oxygen Mask
K220533 · CCK
Engineered Medical Systems, Inc.
Anesthesiology · 265d
Cleared Nov 16, 2022
Heater-Cooler System 3T
K220635 · DWC
Livanova Deutschland, GmbH
Cardiovascular · 257d
Cleared Nov 16, 2022
PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection...
K220841 · DZE
Dentsply Sirona
Dental · 238d
Cleared Nov 16, 2022
OmniTaper EV Dental Implants, DS Implants abutments with EV connection
K221094 · DZE
Dentsply Sirona
Dental · 216d
Cleared Nov 16, 2022
BoneMRI v1.4
K221762 · QIH
Mrlguidance B.V.
Radiology · 152d
Cleared Nov 16, 2022
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA),...
K222364 · OAP
Xtrallux, LLC
General & Plastic Surgery · 104d
Cleared Nov 16, 2022
Life Spine ALIF Buttress Plate System
K222628 · KWQ
Life Spine, Inc.
Orthopedic · 77d
Cleared Nov 15, 2022
LifeSPARC System
K211830 · QNR
Cardiacassist, Inc.
Cardiovascular · 519d
Cleared Nov 15, 2022
Omnia Medical TiBrid-SC
K212612 · OVE
Omnia Medical, LLC
Orthopedic · 455d
Cleared Nov 15, 2022
Dyflex-II
K212700 · NKB
Taeyeon Medical Co., Ltd.
Orthopedic · 447d
Cleared Nov 15, 2022
Cardio10
K220535 · DPS
Bionet Co., Ltd.
Cardiovascular · 264d
Cleared Nov 15, 2022
ALPHALOK Plating System
K221558 · HRS
Vilex, LLC
Orthopedic · 168d
Cleared Nov 15, 2022
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · CAC
Haemonetics Corporation
Cardiovascular · 154d
Cleared Nov 15, 2022
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
K221744 · GAM
Ethicon, Inc.
General & Plastic Surgery · 152d
Cleared Nov 15, 2022
Disposable Sterile Lancet
K222055 · FMK
Tianjin Rilifine Medical Device Co.,...
General & Plastic Surgery · 126d
Cleared Nov 15, 2022
Bloomi Delight Oil-Based Personal Lubricant
K222175 · NUC
The Bloomi Inc..
Obstetrics & Gynecology · 117d
Cleared Nov 15, 2022
Gamma4 System
K222309 · HSB
Stryker GmbH
Orthopedic · 106d
Cleared Nov 15, 2022
Everyway Analog OTC TENS
K222488 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Nov 15, 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 83d
Cleared Nov 15, 2022
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS ,...
K222915 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 50d
Cleared Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
K223199 · HBE
Biomet Microfixation
Neurology · 33d
Cleared Nov 14, 2022
Smith & Nephew Intramedullary Nail Systems
K210980 · HSB
Smith & Nephew, Inc.
Orthopedic · 592d
Cleared Nov 14, 2022
Disposable hemoclip
K213217 · PKL
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 411d