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
16825–16848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2021
AI Segmentation
K203469 · MUJ
Varian Medical Systems, Inc.
Radiology · 145d
Cleared Apr 19, 2021
SOZO
K203473 · DSB
ImpediMed Limited
Gastroenterology & Urology · 145d
Cleared Apr 19, 2021
Arthrex SwiveLock Anchor
K203495 · MAI
Arthrex, Inc.
Orthopedic · 143d
Cleared Apr 19, 2021
Solevy Co. LLC Silicone Based Personal Lubricant
K203644 · NUC
Solevy Co., LLC
Obstetrics & Gynecology · 126d
Cleared Apr 19, 2021
Solevy Co. LLC Water-Based Personal Lubricant
K203654 · NUC
Solevy Co., LLC
Obstetrics & Gynecology · 125d
Cleared Apr 19, 2021
VPS Impression Material
K203824 · ELW
Hygedent, Inc.
Dental · 111d
Cleared Apr 19, 2021
ROSA Partial Knee System
K210121 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 90d
Cleared Apr 19, 2021
Dentis s-Clean s-Line
K210134 · DZE
Dentis Co., Ltd.
Dental · 90d
Cleared Apr 19, 2021
Goblin and Goblin LS Pedicle Screw Systems
K210420 · NKB
Medynus, Inc.
Orthopedic · 67d
Cleared Apr 16, 2021
rainbow MCT
K200270 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 437d
Cleared Apr 16, 2021
rainbow CT
K200271 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 437d
Cleared Apr 16, 2021
Electric Wheelchair (Model: S7110)
K200978 · ITI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 368d
Cleared Apr 16, 2021
Fusion Taper System
K201047 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 360d
Cleared Apr 16, 2021
Looper (Model: ZX-579S)
K202055 · OLP
Heat IN A Click, LLC
General & Plastic Surgery · 266d
Cleared Apr 16, 2021
BIOTECH Nitrile Examination Gloves
K202419 · LZA
Tk Hitech Technology Co., Ltd.
General Hospital · 235d
Cleared Apr 16, 2021
Infrared Thermometer Models: DT-8806S, DT-8807S
K203170 · FLL
Shenzhen Everbest Machinery Industry...
General Hospital · 175d
Cleared Apr 16, 2021
Saige-Q
K203517 · QFM
DeepHealth, Inc.
Radiology · 137d
Cleared Apr 16, 2021
Brainsway Deep (DTMS) System
K203616 · QMD
Brainsway , Ltd.
Neurology · 127d
Cleared Apr 16, 2021
Hair Growth Device
K210169 · OAP
Dongguan Lescolton Intelligent...
General & Plastic Surgery · 84d
Cleared Apr 16, 2021
Disposable Nitrile Gloves
K210276 · LZA
Fujian Ercon Medical Management Co.,...
General Hospital · 74d
Cleared Apr 16, 2021
MOLLI
K210600 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 46d
Cleared Apr 15, 2021
GD Disposable Medical Face Mask
K201718 · FXX
Jiangsu Guangda Medical Material...
General Hospital · 296d
Cleared Apr 15, 2021
SKORE (Colors & Flavors), SKORE (Colors)
K202403 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 237d
Cleared Apr 15, 2021
Axiostat Patch
K202830 · QSY
Advamedica, Inc.
General & Plastic Surgery · 202d