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
13897–13920 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2022
VenSure LightGuide
K212774 · LRC
Intersect Ent.
Ear, Nose, Throat · 156d
Cleared Feb 04, 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849 · LON
Biom?rieux, Inc.
Microbiology · 150d
Cleared Feb 04, 2022
HOLLYWOOD SPECTRA Laser System
K213569 · GEX
Lutronic Corporation
General & Plastic Surgery · 87d
Cleared Feb 04, 2022
Stryker Resorbable Fixation System
K213777 · JEY
Stryker Leibinger Micro Implants
Dental · 63d
Cleared Feb 04, 2022
Veuron-Brain-pAb2
K213801 · LLZ
Heuron Co., Ltd.
Radiology · 60d
Cleared Feb 04, 2022
Revolution Ascend
K213938 · JAK
Ge Healthcare Japan Corporation
Radiology · 50d
Cleared Feb 04, 2022
Radialis PET Camera
K214062 · KPS
Radialis, Inc.
Radiology · 39d
Cleared Feb 04, 2022
Cryo 7
K220020 · GEX
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 30d
Cleared Feb 04, 2022
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · KGE
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Feb 04, 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira...
K220070 · LPL
CooperVision, Inc.
Ophthalmic · 25d
Cleared Feb 04, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K220098 · MQB
Canon, Inc.
Radiology · 23d
Cleared Feb 03, 2022
MectaScrew Extension
K203335 · HWC
Medacta International S.A.
Orthopedic · 448d
Cleared Feb 03, 2022
Healing Abutment, Cover Screw
K210826 · NHA
Megagen Implant Co., Ltd.
Dental · 321d
Cleared Feb 03, 2022
LifePath Remote Patient Monitoring Platform
K211822 · DRG
Elastic Care Incorporated
Cardiovascular · 234d
Cleared Feb 03, 2022
Ambu® aScope™ Gastro, Ambu® aBox™2
K212382 · FDS
Ambu A/S
Gastroenterology & Urology · 185d
Cleared Feb 03, 2022
Sonopet iQ Ultrasonic Aspirator System
K213824 · LFL
Stryker Corporation
General & Plastic Surgery · 57d
Cleared Feb 03, 2022
Contour ProtégéAI
K213976 · QKB
Mim Software, Inc.
Radiology · 45d
Cleared Feb 03, 2022
Soniquence Reusable Neutral Plate
K220071 · GEI
Soniquence, LLC
General & Plastic Surgery · 24d
Cleared Feb 02, 2022
NATtrol BD MAX Vaginal Panel External Controls
K201403 · PMN
Zeptometrix
Microbiology · 615d
Cleared Feb 02, 2022
EndoSerter-PL
K203586 · OTZ
Corneagen, Inc.
Ophthalmic · 421d
Cleared Feb 02, 2022
EVOCLEAN CLEANsert Ultrasonic Insert
K210832 · ELC
Ttbio Corp.
Dental · 320d
Cleared Feb 02, 2022
Rosso
K211228 · GEX
Quanta System Spa
General & Plastic Surgery · 285d
Cleared Feb 02, 2022
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses,...
K211603 · LPL
Pegavision Corporation
Ophthalmic · 254d
Cleared Feb 02, 2022
TeesuVac Breast Biopsy Device Mark 1
K212079 · KNW
Teesuvac Aps
General & Plastic Surgery · 215d