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
27841–27864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2017
higi Station (with Body Composition and Pan and Tilt cuff housing), higi...
K172739 · DXN
Higi Sh, LLC
Cardiovascular · 28d
Cleared Oct 06, 2017
Bilicocoon™ Phototherapy System
K163526 · LBI
Neomedlight
General Hospital · 294d
Cleared Oct 06, 2017
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood...
K170079 · NBW
Tyson Bioresearch, Inc.
Chemistry · 269d
Cleared Oct 06, 2017
U-Motion II Acetabular System— Additional sizes
K170089 · LZO
United Orthopedic Corporation
Orthopedic · 269d
Cleared Oct 06, 2017
MSA100BT Peak Flow Meter
K170281 · BZH
Beijing M&B Electronic Instruments...
Anesthesiology · 249d
Cleared Oct 06, 2017
Low Profile Non-Balloon Feeding Device
K170319 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 247d
Cleared Oct 06, 2017
Kisses Mini
K170394 · DZE
Achimhai Medical Corporation
Dental · 240d
Cleared Oct 06, 2017
Digital Eye Anterior Camera
K170470 · HJO
Medimaging Integrated Solution, Inc...
Ophthalmic · 232d
Cleared Oct 06, 2017
Tamper Evident Cap For use with ENFit Syringes
K170672 · PNR
International Medical Industries, Inc.
Gastroenterology & Urology · 214d
Cleared Oct 06, 2017
Sienna Ultimate Wireless Amplifier
K171397 · GWL
Ems Handels Gesellschaft M.B.H.
Neurology · 148d
Cleared Oct 06, 2017
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3
K171801 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 112d
Cleared Oct 06, 2017
Reprocessed Ethicon Bladeless Trocars
K172097 · NLM
Renovo, Inc.
Gastroenterology & Urology · 87d
Cleared Oct 06, 2017
Aquilion Prime SP, TSX-303B/1, v8.4
K172188 · JAK
Toshiba Medical Systems Coroporation
Radiology · 78d
Cleared Oct 06, 2017
MicroMatrix
K172399 · KGN
Acell, Inc.
General & Plastic Surgery · 59d
Cleared Oct 06, 2017
Ingenuity TF
K172406 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 58d
Cleared Oct 06, 2017
MT ONE
K172413 · GEX
M&T S.R.L.
General & Plastic Surgery · 57d
Cleared Oct 06, 2017
Endoscopic Applicator, 41 cm
K172672 · GCJ
Micromedics, Inc. (D/B/A Nordson...
General & Plastic Surgery · 31d
Cleared Oct 06, 2017
Edge Air Digital Flat Panel X-ray Detector
K172681 · MQB
Osko, Inc.
Radiology · 30d
Cleared Oct 06, 2017
Edge Digital Flat Panel X-ray Detector
K172682 · MQB
Osko, Inc.
Radiology · 30d
Cleared Oct 05, 2017
Shanghai Sanyou CARMEN Cervical Fusion System
K163366 · KWQ
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 309d
Cleared Oct 05, 2017
Gold AQ Blood Glucose Monitoring System
K170264 · NBW
Changsha Sinocare, Inc.
Chemistry · 251d
Cleared Oct 05, 2017
Tahoe Uni Knee System
K170344 · HSX
Consensus Orthopedics, Inc.
Orthopedic · 244d
Cleared Oct 05, 2017
Medacta Shoulder System
K170452 · PHX
Medacta International S.A.
Orthopedic · 232d
Cleared Oct 05, 2017
InSure ONE
K170548 · KHE
Enterix, Inc.
Hematology · 223d