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
13609–13632 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2022
PHantom Trilogy
K213534 · OLI
Resurgeonz, LLC
General & Plastic Surgery · 126d
Cleared Mar 11, 2022
Shoulder Innovations Total Shoulder System
K213615 · PKC
Shoulder Innovations, Inc.
Orthopedic · 116d
Cleared Mar 11, 2022
DEKA SMARTPERIO
K213658 · NVK
El.En Electronic Engineering Spa
Dental · 112d
Cleared Mar 11, 2022
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR...
K213687 · MOS
Neocoil, LLC
Radiology · 108d
Cleared Mar 11, 2022
Pectus Support Bar System
K213712 · HRS
Biomet Microfixation
Orthopedic · 107d
Cleared Mar 11, 2022
CardIQ Suite
K213725 · JAK
GE Medical Systems SCS
Radiology · 105d
Cleared Mar 11, 2022
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN...
K213827 · KWS
Smith & Nephew, Inc.
Orthopedic · 93d
Cleared Mar 11, 2022
Intracept Intraosseous Nerve Ablation System
K213836 · GXI
Relievant Medsystems, Inc.
Neurology · 92d
Cleared Mar 11, 2022
EmbryoSlide+ ic8 dish
K213869 · MQK
Vitrolife A/S
Obstetrics & Gynecology · 88d
Cleared Mar 11, 2022
Demetra Dermatoscope BDEM-01
K213957 · PSN
Barco N.V.
General & Plastic Surgery · 84d
Cleared Mar 11, 2022
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
K220315 · MTJ
Orthocon, Inc.
Orthopedic · 36d
Cleared Mar 11, 2022
EndoGator Endoscopy Irrigation Tubing
K220395 · FEQ
STERIS Corporation
Gastroenterology & Urology · 28d
Cleared Mar 11, 2022
Dental sensors NanoPix1, NanoPix2
K220422 · MUH
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Mar 11, 2022
MAGNETOM Vida, MAGNETOM Sola
K220425 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 10, 2022
One Step Pregnancy Test
K210341 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 398d
Cleared Mar 10, 2022
D-Laser Blue, D-Laser 16
K210367 · NVK
Guilin Woodpecker Medical Instrument...
Dental · 395d
Cleared Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy...
K211911 · LJE
Coloplast Corp.
Gastroenterology & Urology · 262d
Cleared Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for...
K212148 · LZA
Ansell Healthcare Products, LLC
General Hospital · 244d
Cleared Mar 10, 2022
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
K212165 · PNE
Innovative Health, LLC
Cardiovascular · 241d
Cleared Mar 10, 2022
SIGNUS SACRONAIL® Transsacral Stabilization System
K212755 · HWC
Signus Medizintechnik GmbH
Orthopedic · 191d
Cleared Mar 10, 2022
Smile-100 System
K212965 · LHQ
Niramai Health Analytix Private Limited
Radiology · 175d
Cleared Mar 10, 2022
Infrared Forehead Thermometer, model: HS-9802D
K213038 · FLL
Jiaxing Shangjia Intelligence...
General Hospital · 170d
Cleared Mar 10, 2022
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with...
K213373 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 149d
Cleared Mar 10, 2022
GLP systems Track
K213486 · JGS
Abbott Laboratories
Chemistry · 132d