FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2377–2400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2025
Disposable Hot Biopsy Forceps (FD-210U)
K250187 · KGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 258d
Cleared Oct 07, 2025
Ultrasound Therapy Workstation (XMS-UET2)
K244041 · IMG
Xemis Medical Technology (Shenzhen)...
Physical Medicine · 281d
Cleared Oct 06, 2025
Folding Mobility Scooter (KD101)
K252502 · INI
Nanjing Kangni Smart Technology Co.,...
Physical Medicine · 59d
Cleared Oct 06, 2025
Heylo™ System
K252140 · EXB
Coloplast Corp.
Gastroenterology & Urology · 90d
Cleared Oct 06, 2025
BlineSlide
K252007 · QIH
Deep Breathe, Inc.
Radiology · 101d
Cleared Oct 06, 2025
Tigertriever 17 Ultra Revascularization Device
K251603 · NRY
Rapid Medical , Ltd.
Neurology · 132d
Cleared Oct 06, 2025
Wheelchair (N817)
K251565 · ITI
Zhejiang Topwe Tools Manufacturing...
Physical Medicine · 137d
Cleared Oct 06, 2025
Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal...
K250173 · BTR
Covidien, LLC
Anesthesiology · 258d
Cleared Oct 03, 2025
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso)
K252820 · GAM
Internacional Farmac?utica S.A DE C.V
General & Plastic Surgery · 29d
Cleared Oct 03, 2025
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU,...
K252806 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 30d
Cleared Oct 03, 2025
Manual Wheelchair (SYIV100A008)
K252517 · IOR
Ningbo Shenyu Medical Equipment Co.,Ltd
Physical Medicine · 53d
Cleared Oct 03, 2025
MAGENTIQ-COLO (ME-APDS)
K252178 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 84d
Cleared Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · PKC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 03, 2025
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K251859 · ODG
Olympus Medical Systems Corporation
Gastroenterology & Urology · 108d
Cleared Oct 03, 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
K251646 · OMP
Alleva Medical Devices
General & Plastic Surgery · 127d
Cleared Oct 03, 2025
xvision Spine system
K251639 · SBF
Augmedics, Ltd.
Orthopedic · 127d
Cleared Oct 03, 2025
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket...
K251468 · EZD
Hollister Incorporated
Gastroenterology & Urology · 143d
Cleared Oct 03, 2025
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
K251464 · GEX
Jeisys Medical Incorporated
General & Plastic Surgery · 143d
Cleared Oct 03, 2025
da Vinci SP Surgical System (SP1098)
K251426 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 148d
Cleared Oct 03, 2025
Bunkerhill MAC
K250662 · JAK
BunkerHill Health
Radiology · 212d
Cleared Oct 03, 2025
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
K250073 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 266d
Cleared Oct 03, 2025
HPACS
K250039 · LLZ
Healthhub
Radiology · 268d
Cleared Oct 03, 2025
Amplatzer Guidewire
K250031 · DQX
Abbott Medical
Cardiovascular · 269d
Cleared Oct 03, 2025
Anti Snore Mouthpiece
K250028 · LRK
Dongguan Yiyao Science & Technology...
Dental · 270d