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
18841–18864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2020
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N...
K200318 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 258d
Cleared Oct 22, 2020
Voluson E10
K201768 · IYN
Ge Healthcare
Radiology · 115d
Cleared Oct 22, 2020
Broncoflex Agile
K202180 · EOQ
Axess Vision Technology
Ear, Nose, Throat · 79d
Cleared Oct 22, 2020
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
K202428 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 58d
Cleared Oct 22, 2020
GEO Bone Screw System
K202817 · HWC
Gramercy Extremity Orthopedics, LLC
Orthopedic · 28d
Cleared Oct 22, 2020
EzOrtho
K202948 · LLZ
Ewoosoft Co., Ltd.
Radiology · 22d
Cleared Oct 21, 2020
C4 Fiducial Marker
K192771 · NEU
C4 Imaging, LLC
General & Plastic Surgery · 387d
Cleared Oct 21, 2020
InnovaMatrix
K193552 · KGN
Triad Life Sciences, Inc.
General & Plastic Surgery · 306d
Cleared Oct 21, 2020
PRO-DENSE LoVisc Bone Graft Substitute
K200507 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Oct 21, 2020
PleurX Peritoneal Catheter System
K201155 · PNG
Care Fusion
Gastroenterology & Urology · 174d
Cleared Oct 21, 2020
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59%...
K201268 · LPL
Plexus Optix, Inc.
Ophthalmic · 162d
Cleared Oct 21, 2020
Vial2Bag Advanced 20mm Admixture Device
K201415 · LHI
West Pharmaceutical Services Az, Inc.
General Hospital · 145d
Cleared Oct 21, 2020
Trivergent Spinal Fixation System
K201427 · NKB
Benvenue Medical, Inc.
Orthopedic · 145d
Cleared Oct 21, 2020
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI...
K201438 · GMQ
Arlington Scientific, Inc. (Asi)
Microbiology · 142d
Cleared Oct 21, 2020
IonicRF Generator
K201610 · GXD
Abbott Medical
Neurology · 128d
Cleared Oct 21, 2020
YSIO X.pree
K201670 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 124d
Cleared Oct 21, 2020
S.I.N. Instrument Kits
K201688 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 121d
Cleared Oct 21, 2020
Pentacam AXL Wave
K201724 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 120d
Cleared Oct 21, 2020
ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew...
K201884 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 105d
Cleared Oct 21, 2020
OASIS MRI System
K202030 · LNH
Hitachi Healthcare Americas
Radiology · 91d
Cleared Oct 21, 2020
Powerpress Recovery Unit
K202044 · IRP
Hanuri Distribution, Inc.
Physical Medicine · 90d
Cleared Oct 21, 2020
ACTIS Duofix Hip Prosthesis
K202472 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 54d
Cleared Oct 21, 2020
Iridex 810 Laser
K202760 · HQF
Iridex Corporation
Ophthalmic · 30d
Cleared Oct 21, 2020
EVA15
K202799 · HIF
Palliare , Ltd.
Obstetrics & Gynecology · 28d