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

Filters: Cleared only ×
175,820 results
12625–12648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2022
Klarity SRS Baseplate, Klarity Promise Baseplate
K220539 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 249d
Cleared Nov 01, 2022
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe...
K221247 · MEG
Jiangsu Kangbao Medical Equipment...
General Hospital · 183d
Cleared Nov 01, 2022
Dolphin Blue Imaging
K221478 · LLZ
Patterson Dental Supply, Inc.
Radiology · 162d
Cleared Nov 01, 2022
Combined High Frequency X-ray Source
K222258 · IZL
Suzhou Powersite Electric Co., Ltd.
Radiology · 97d
Cleared Nov 01, 2022
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
K222508 · JOJ
3M Company
General Hospital · 75d
Cleared Nov 01, 2022
Current Health System
K222550 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Nov 01, 2022
POSE™ Health Care Surgical Mask
K223270 · FXX
America?S Supply Chains
General Hospital · 8d
Cleared Oct 31, 2022
ORiGO System
K213697 · HBC
Bien-Air Surgery SA
Neurology · 342d
Cleared Oct 31, 2022
IO Needle Safety Sheath
K220890 · FMI
Actuated Medical, Inc.
General Hospital · 217d
Cleared Oct 31, 2022
Excelsior
K220929 · NFJ
Merit Cro, Inc.
Ophthalmic · 214d
Cleared Oct 31, 2022
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
K221810 · MQK
Bonraybio Co., Ltd.
Obstetrics & Gynecology · 131d
Cleared Oct 31, 2022
Standard Tapered Bougie, 38 Fr.
K222085 · KNT
Standard Bariatrics, Inc.
Gastroenterology & Urology · 108d
Cleared Oct 31, 2022
Fresenius Liberty Select Cycler
K222318 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Oct 31, 2022
CL24N
K222717 · PGY
Wide Corporation
Radiology · 53d
Cleared Oct 31, 2022
CW60N
K222722 · PGY
Wide Corporation
Radiology · 53d
Cleared Oct 30, 2022
Nuheara IQbuds 2 PRO Hearing Aid
K221064 · QUH
Nuheara Limited
Ear, Nose, Throat · 202d
Cleared Oct 28, 2022
Disposable Surgical Gown Rk-3011C
K211060 · FYA
Xiantao Rhycom Non-Woven Products...
General Hospital · 567d
Cleared Oct 28, 2022
Welch Allyn Connex Central Station
K212473 · MWI
Welch Allyn, Inc.
Cardiovascular · 448d
Cleared Oct 28, 2022
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
K214109 · GXN
Kontour(Xi?An) Medical Technology...
Neurology · 303d
Cleared Oct 28, 2022
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
K220305 · PZX
Syntheon
Cardiovascular · 268d
Cleared Oct 28, 2022
Vapotherm Aerosol Adapter AAA-2
K220869 · CAF
Vapotherm, Inc.
Anesthesiology · 217d
Cleared Oct 28, 2022
Vented Vial Transfer Pin
K221406 · LHI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 165d
Cleared Oct 28, 2022
SUPERTILT PLUS (STP)
K221435 · IOR
Power Plus Mobility
Physical Medicine · 164d
Cleared Oct 28, 2022
Disposable Safety Lancet
K221521 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 156d