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
13921–13944 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 01, 2022
JETi AIO Peripheral Thrombectomy System
K213565 · QEZ
Walk Vascular, LLC
Cardiovascular · 84d
Cleared Feb 01, 2022
Exeter® X3® RimFit® Cup
K213701 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 69d
Cleared Feb 01, 2022
Home use hair removal device, model: Precise Touch Pro
K213830 · OHT
Iluminage Beauty Co., Limited
General & Plastic Surgery · 55d
Cleared Feb 01, 2022
Permadyne
K220257 · ELW
3M Deutschland GmbH
Dental · 1d
Cleared Jan 31, 2022
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · JHI
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 451d
Cleared Jan 31, 2022
MIS Precision Chevron Bunion System
K211628 · HWC
Relja Innovations, LLC
Orthopedic · 249d
Cleared Jan 31, 2022
Primary Relief
K213188 · NHI
Dyansys, Inc.
Neurology · 124d
Cleared Jan 31, 2022
DIAPLUS Universal
K213401 · KLE
DiaDent Group International
Dental · 105d
Cleared Jan 31, 2022
SKR 3000
K213908 · MQB
Konica Minolta, Inc.
Radiology · 48d
Cleared Jan 31, 2022
8mm Monopolar Curved Scissors
K220023 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Jan 28, 2022
syngo.CT Brain Hemorrhage
K203260 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 449d
Cleared Jan 28, 2022
Platform treatment system
K203395 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 436d
Cleared Jan 28, 2022
Optiflow Oxygen Kit
K211096 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 290d
Cleared Jan 28, 2022
Surgical Masks
K212120 · FXX
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 205d
Cleared Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
K212341 · DTZ
Qura S.R.L
Cardiovascular · 184d
Cleared Jan 28, 2022
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
K212533 · DZE
Institut Straumann AG
Dental · 170d