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: 2026–2026 ×
1,922 results
673–696 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 21, 2026
Sphincterotome
K260962 · KNS
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 59d
Cleared May 21, 2026
OES ELITE Cystoscope and Accessories
K260649 · FAJ
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 83d
Cleared May 21, 2026
Ulthera® System
K260618 · OHV
Ulthera, Inc.
General & Plastic Surgery · 85d
Cleared May 21, 2026
ROSA® Shoulder System
K260582 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 90d
Cleared May 21, 2026
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K260580 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 21, 2026
MSK Go
K260234 · QIH
Smart Alfa Teknoloji San. Ve Tic. A.S.
Radiology · 115d
Cleared May 21, 2026
pjur NATURE Touch, 100 ml
K260068 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 132d
Cleared May 21, 2026
PanopticAI Vital Signs (1.6.1-22)
K260066 · QME
PanopticAI technologies Limited
Cardiovascular · 132d
Cleared May 21, 2026
Wearable Breast Pump (Model S39)
K254244 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 143d
Cleared May 21, 2026
Manual Wheelchair (DY01903(2))
K254141 · IOR
Guangdong Dayang Medical Technology...
Physical Medicine · 150d
Cleared May 21, 2026
BAC
K254131 · QIH
DeepHealth, Inc.
Radiology · 150d
Cleared May 21, 2026
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015,...
K253956 · FTL
Sofradim Production
General & Plastic Surgery · 162d
Cleared May 21, 2026
MuCover (proposed name) Oral Wound Dressing
K253816 · OLR
MoleculeX Co., Ltd.
Dental · 174d
Cleared May 21, 2026
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite,...
K253720 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 178d
Cleared May 21, 2026
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses
K253352 · LPL
Pegavision Corporation
Ophthalmic · 233d
Cleared May 21, 2026
Boston 2910 (Boston 2910)
K253245 · GEX
Boston Aesthetics, Inc.
General & Plastic Surgery · 234d
Cleared May 21, 2026
DCMhotbond zircon
K253191 · EIH
Dental Creativ Management GmbH
Dental · 237d
Cleared May 21, 2026
Sofjec (Single use Needle)
K253112 · FMF
Hlb Lifescience Co., Ltd.
General Hospital · 239d
Cleared May 21, 2026
Atlan (A100)
K252746 · BSZ
Dr?gerwerk AG & Co KGaA
Anesthesiology · 265d
Cleared May 21, 2026
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B...
K251920 · BZD
Dcstar, Inc.
Anesthesiology · 332d
Not Cleared May 21, 2026
DeepView AI® System
DEN250028 · SHY
Spectralmd, Inc.
General & Plastic Surgery · 328d
Cleared May 20, 2026
The Circadia C300 System (C300)
K261286 · DRT
Circadia Health, Inc.
Cardiovascular · 30d
Cleared May 20, 2026
Mobility Scooter (Air Carbon)
K260717 · INI
Suzhou Sweetrich Vehicle Industry...
Physical Medicine · 76d
Cleared May 20, 2026
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG,...
K260594 · OHT
Shenzhen Xiazhifeng Electronic Co., Ltd.
General & Plastic Surgery · 86d