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
2329–2352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2025
TMINI Miniature Robotic System
K252544 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Oct 10, 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · HWC
Dev4
Orthopedic · 78d
Cleared Oct 10, 2025
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028,...
K252209 · OHT
Foshan Jindi Electric Appliance Co.,...
General & Plastic Surgery · 87d
Cleared Oct 10, 2025
Collagen Wound Dressing
K252001 · KGN
Winner Medical Co., Ltd.
General & Plastic Surgery · 105d
Cleared Oct 10, 2025
Zeta Navigation System (ZNS131-US)
K251927 · SGE
Zeta Surgical, Inc.
Neurology · 109d
Cleared Oct 10, 2025
Tegaderm Post-Op Transparent Antimicrobial Dressing
K251866 · FRO
Solventum US, LLC
General & Plastic Surgery · 115d
Cleared Oct 10, 2025
Yomi Robotic System
K251835 · PLV
Neocis, Inc.
Dental · 116d
Cleared Oct 10, 2025
EvoEndo Single-Use Endoscopy System
K251708 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 129d
Cleared Oct 10, 2025
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
K251602 · OWB
Canon Medical Systems Corporation
Radiology · 136d
Cleared Oct 10, 2025
HYDROS Robotic System (HY1000)
K251082 · PZP
Procept Biorobotics
Gastroenterology & Urology · 184d
Cleared Oct 10, 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U)
K250351 · KNS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 245d
Cleared Oct 10, 2025
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated...
K250249 · GMQ
Gold Standard Diagnostics, LLC
Microbiology · 256d
Cleared Oct 10, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · NBW
ACON Laboratories, Inc.
Chemistry · 270d
Cleared Oct 10, 2025
SoClean 3+
K243815 · QXQ
Soclean, Inc.
General Hospital · 303d
Cleared Oct 10, 2025
HexaPLUS S OneDrill Implant System
K243078 · DZE
Osseofuse International, Inc.
Dental · 375d
Cleared Oct 09, 2025
iFuse Bedrock Granite Implant System
K253094 · OUR
SI-BONE, Inc.
Orthopedic · 16d
Cleared Oct 09, 2025
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
K252939 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 24d
Cleared Oct 09, 2025
Lux HD 2530 detector (Lux HD 2530)
K252911 · MQB
Iray Imaging Technology (Haining)...
Radiology · 27d
Cleared Oct 09, 2025
Orca Air/Water and Suction Valves
K252910 · ODC
Boston Scientific
Gastroenterology & Urology · 27d
Cleared Oct 09, 2025
Invisalign Specifix Attachment System
K252870 · NXC
Align Technology, Inc.
Dental · 30d
Cleared Oct 09, 2025
VINScreen Urine Drug Test Cup
K252867 · NFT
Advin Biotech, Inc.
Toxicology · 30d
Cleared Oct 09, 2025
Pediatric Plating Platform I Small-Mini
K252600 · HRS
OrthoPediatrics Corp.
Orthopedic · 52d
Cleared Oct 09, 2025
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004,...
K252553 · NFO
Shenzhen Jianchao Intelligent...
Neurology · 57d
Cleared Oct 09, 2025
ORA Method LED Gua Sha (GS-04)
K252272 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 79d