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
7081–7104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2024
Multi-function Platform Systems (BL-M10)
K240474 · GEX
Shanghai Bele Medical Technology Co.,Ltd
General & Plastic Surgery · 90d
Cleared May 20, 2024
MIM - Centiloid Scaling
K233620 · LLZ
Mim Software, Inc.
Radiology · 189d
Cleared May 20, 2024
Fogarty Corkscrew Catheters
K233619 · DXE
Edwards Lifesciences
Cardiovascular · 189d
Cleared May 20, 2024
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430,...
K233341 · BTR
Covidien, LLC
Anesthesiology · 234d
Cleared May 20, 2024
Solo+ Tympanostomy Tube Device (TTD)
K232702 · ETD
Aventamed Dac
Ear, Nose, Throat · 258d
Cleared May 20, 2024
AViTA Pulse Oximeter
K223399 · DQA
Avita Corporation
Anesthesiology · 558d
Cleared May 17, 2024
MiRus MoRe Lumbar Plating System
K241175 · KWQ
MiRus, LLC
Orthopedic · 21d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · DRC
Pressure Products Medical Device...
Cardiovascular · 30d
Cleared May 17, 2024
ARENAL Anterior Cervical Plate System
K240935 · KWQ
Effortmed, LLC
Orthopedic · 42d
Cleared May 17, 2024
Intense Pulsed Light System (ST-690)
K240482 · ONF
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared May 17, 2024
CIRRUS™ HD-OCT Model 6000
K233933 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 155d
Cleared May 17, 2024
Radiance V5
K233236 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 232d
Cleared May 17, 2024
icotec Anterior Cervical Plate System
K233215 · KWQ
Icotec AG
Orthopedic · 234d
Cleared May 17, 2024
uOmnispace.CT
K233209 · QIH
Shanghai United Imaging Healthcare...
Radiology · 232d
Cleared May 17, 2024
Curlin 8000 Ambulatory Infusion System
K232793 · FRN
Zevex, Inc.
General Hospital · 249d
Cleared May 17, 2024
Yoni.Fit Bladder Support
K232525 · HHW
Watkins-Conti Products, Inc.
Gastroenterology & Urology · 270d
Cleared May 17, 2024
Sentec Digital Monitoring System (SDMS) tCOM+
K232516 · LKD
Sentec AG
Anesthesiology · 273d
Cleared May 17, 2024
Kahook Dual Blade Glide (KDB Glide)
K220891 · QUQ
New World Medical, Inc.
Ophthalmic · 781d
Cleared May 16, 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 30d
Cleared May 16, 2024
DEKA TORO
K240752 · GEX
El.En S.P.A.
General & Plastic Surgery · 58d
Cleared May 16, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K240445 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared May 16, 2024
Picosecond Nd:YAG Laser Systems (BL-C10)
K240386 · GEX
Shanghai Bele Medical Technology Co.,Ltd
General & Plastic Surgery · 98d
Cleared May 16, 2024
eXciteOSA without remote control (3000)
K240328 · QNO
Signifier Medical Technologies, Ltd.
Dental · 101d
Cleared May 16, 2024
FAgamin®
K240059 · PHR
Tedequim Srl
Dental · 129d