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
25417–25440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2018
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K181016 · NFJ
Welch Allyn, Inc.
Ophthalmic · 90d
Cleared Jul 16, 2018
Diode Laser System
K181019 · GEX
Guangzhou Huafei Tongda Technology...
General & Plastic Surgery · 90d
Cleared Jul 16, 2018
CxHA PEEK Cervical IBF System
K181115 · ODP
Innovasis, Inc.
Orthopedic · 80d
Cleared Jul 16, 2018
Embosphere Microspheres
K181300 · KRD
Biosphere Medical, S.A.
Neurology · 60d
Cleared Jul 16, 2018
PathLoc-SI Joint Fusion System
K181600 · OUR
L & K Biomed Co., Ltd.
Orthopedic · 28d
Cleared Jul 15, 2018
Solana Bordetella Complete Assay
K181029 · OZZ
Quidel Corporation
Microbiology · 88d
Cleared Jul 13, 2018
Sterile Latex Surgical Gloves, Powder Free
K171550 · KGO
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 413d
Cleared Jul 13, 2018
IRRAflow CNS System
K171880 · JXG
Irras, Inc.
Neurology · 385d
Cleared Jul 13, 2018
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
K172440 · INI
Dongguan Prestige Sporting Goods., Ltd.
Physical Medicine · 336d
Cleared Jul 13, 2018
Surgical gown (AE1001, AE2001, AE3001)
K172987 · FYA
Gmax Industries, Inc.
General Hospital · 289d
Cleared Jul 13, 2018
Yikang Latex Foley Catheter
K173340 · EZL
Jiangxi Yikang Medical Instrument...
Gastroenterology & Urology · 263d
Cleared Jul 13, 2018
Injection Screw
K173556 · HWC
Biedermann Medtech, Inc.
Orthopedic · 238d
Cleared Jul 13, 2018
Dimension Hemoglobin A1c Assay
K173909 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 203d
Cleared Jul 13, 2018
Pulmonx Chartis Tablet Console
K180011 · BZG
Pulmonx Corporation
Anesthesiology · 192d
Cleared Jul 13, 2018
PINXEL-RF system
K180654 · GEI
Rohrer Aesthetics, LLC
General & Plastic Surgery · 122d
Cleared Jul 13, 2018
Viking Lumbar Polyaxial Screw System
K180655 · NKB
Presidio Surgical
Orthopedic · 122d
Cleared Jul 13, 2018
Normandy VBR System
K180673 · PLR
Zavation Medical Products, LLC
Orthopedic · 121d
Cleared Jul 13, 2018
Kestrel™ Buttress Plate System
K181063 · KWQ
Innovasis, Inc.
Orthopedic · 81d
Cleared Jul 13, 2018
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M...
K181134 · LFD
Sunstar Americas, Inc.
Dental · 74d
Cleared Jul 13, 2018
EliA M2 Immunoassay
K181556 · DBM
Phadia AB
Immunology · 30d
Cleared Jul 13, 2018
Aquarius 8600 Digital Radiography Sensor
K181565 · MQB
Biokinemetrics, Inc.
Radiology · 29d
Cleared Jul 13, 2018
Tinnitus Sound Generator Module
K181586 · KLW
GN Hearing A/S
Ear, Nose, Throat · 28d
Cleared Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
K171274 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 437d
Cleared Jul 12, 2018
Infrared Thermometer
K172874 · FLL
Shenzhen Jiacom Technology CO ., Ltd.
General Hospital · 294d