FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12025–12048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2022
Led Mask Platinum Md
K222377 · OHS
Cellreturn Co., Ltd.
General & Plastic Surgery · 90d
Cleared Nov 03, 2022
truSculpt iD
K223110 · GEI
Cutera, Inc.
General & Plastic Surgery · 31d
Cleared Nov 03, 2022
Tera Harz Clear
K223355 · NXC
Graphy, Inc.
Dental · 1d
Cleared Nov 02, 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for...
K211816 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 509d
Cleared Nov 02, 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded...
K220371 · LZA
Summit Glove, Inc.
General Hospital · 266d
Cleared Nov 02, 2022
ORiGO System
K221184 · ERL
Bien-Air Surgery SA
Ear, Nose, Throat · 191d
Cleared Nov 02, 2022
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance...
K222084 · FMK
Asahi Polyslider Co., Ltd.
General & Plastic Surgery · 110d
Cleared Nov 02, 2022
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
K222395 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 86d
Cleared Nov 02, 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K223320 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 5d
Cleared Nov 01, 2022
Back 3 COLOR
K214090 · PBX
Swims America Corp
General & Plastic Surgery · 308d
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