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
4777–4800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02,...
K243155 · FGB
Dongguan Zsr Biomedical Technology...
Gastroenterology & Urology · 134d
Cleared Feb 11, 2025
MOR
K241897 · QRC
Morari, Inc.
Gastroenterology & Urology · 228d
Cleared Feb 11, 2025
InSet Total Shoulder System
K241817 · KWT
Shoulder Innovations, Inc.
Orthopedic · 232d
Cleared Feb 11, 2025
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
K241634 · DXN
Guangdong Xinyu Electronic and...
Cardiovascular · 250d
Cleared Feb 11, 2025
LONGY Implant and LONGY-N Implant
K241462 · DZE
Noris Medical , Ltd.
Dental · 264d
Cleared Feb 11, 2025
Rusch Endotracheal Tubes (Reinforced)
K241451 · BTR
Teleflex Incorporated
Anesthesiology · 265d
Cleared Feb 11, 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
K240867 · QQX
Roche Molecular Systems, Inc.
Microbiology · 319d
Cleared Feb 10, 2025
Calcium2
K244042 · CJY
Abbott Ireland
Chemistry · 42d
Cleared Feb 10, 2025
Remi Custom Night Guard
K243516 · MQC
Grindguard, Inc.
Dental · 89d
Cleared Feb 10, 2025
OTC TENS & EMS Unit
K243511 · NGX
Changsha Anxiang Medical Technology...
Physical Medicine · 90d
Cleared Feb 10, 2025
Philips Lumea IPL
K243453 · OHT
Philips Consumer Lifestyle B.V.
General & Plastic Surgery · 95d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Thermo Fisher Scientific
Microbiology · 132d
Cleared Feb 10, 2025
Myolight Microcurrent Handpiece
K243063 · NFO
Raja Trading Company, Inc.
Neurology · 136d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Feb 10, 2025
Ultrasound Workspace (UWS 6.0)
K241659 · QIH
Philips Ultrasound, LLC
Radiology · 245d
Cleared Feb 10, 2025
BTL-398
K241516 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 257d
Cleared Feb 10, 2025
Locking Plates and Screws Systems
K240958 · HRS
Hebei Ruihe Medical Devices Co., Ltd.
Orthopedic · 308d
Cleared Feb 07, 2025
AssureTech Panel Dip Tests
K243996 · NFT
Assure Tech., LLC
Toxicology · 43d
Cleared Feb 07, 2025
HELIOS 785 Pico (1754V2)
K243780 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 60d
Cleared Feb 07, 2025
Electronic Blood Pressure Monitor
K243661 · DXN
Hetaida Technology Co., Ltd.
Cardiovascular · 72d
Cleared Feb 07, 2025
Endoscopic Video Image Processor (RP-IPD-V1000F)
K243321 · FET
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 107d
Cleared Feb 07, 2025
Identify (4.0)
K242957 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Feb 07, 2025
Any-Com Bulk
K242713 · EBF
Mediclus Co., Ltd.
Dental · 151d
Cleared Feb 07, 2025
Genesys Spine AIS-C II Cervical Interbody Fusion System
K242483 · OVE
Genesys Spine
Orthopedic · 170d