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

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175,820 results
15001–15024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 02, 2022
Sentient Manufacturing Laser Fiber
K213554 · GEX
Sentient Manufacturing , LLC
General & Plastic Surgery · 86d
Cleared Feb 02, 2022
PALACOS MV pro
K213812 · LOD
Heraeus Medical GmbH
Orthopedic · 57d
Cleared Feb 02, 2022
Viveve 2.0 System
K213814 · GEI
Viveve, Inc.
General & Plastic Surgery · 57d
Cleared Feb 01, 2022
Infinity Acute Care System (IACS) Monitoring System
K203088 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 476d
Cleared Feb 01, 2022
HotDog Warming Mattress + Return Electrode
K210727 · GEI
Augustine Temperature Management, LLC
General & Plastic Surgery · 327d
Cleared Feb 01, 2022
X-Guide® Surgical Navigation System
K211701 · QRY
X-Nav Technologies, LLC
Dental · 243d
Cleared Feb 01, 2022
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
K212410 · MQL
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 182d
Cleared Feb 01, 2022
CO2 Laser Equipment
K212611 · GEX
Beijing Globalipl Development Co., Ltd.
General & Plastic Surgery · 168d