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: 2026–2026 ×
2,517 results
1273–1296 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared May 20, 2026
Numen™ Helia Coil Embolization System
K260351 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 106d
Cleared May 20, 2026
WAVE PTA Balloon Catheter
K260304 · LIT
WAVE Medical AG
Cardiovascular · 110d
Cleared May 20, 2026
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM...
K260098 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 127d
Cleared May 20, 2026
Derma-2
K253911 · LHQ
Neko Health AB
Radiology · 163d
Cleared May 20, 2026
Elos Accurate® Denture Fixation System
K253774 · NHA
Elos Medtech Pinol A/S
Dental · 175d