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
2425–2448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2025
PRO-DOSE System
K250083 · NZT
Nu-Rise, SA
Radiology · 261d
Cleared Oct 01, 2025
Shear Wave Quantificational Ultrasound Diagnostic System...
K250026 · IYN
Wuxi Hisky Medical Technologies Co.,...
Radiology · 268d
Cleared Sep 30, 2025
Biopsy Forceps
K252722 · DWZ
Fehling Instruments GmbH
Cardiovascular · 33d
Cleared Sep 30, 2025
External Fixation Mini Rail System
K252106 · KTT
Paragon 28, Inc.
Orthopedic · 89d
Cleared Sep 30, 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · MQV
Wright Medical Technology, Inc....
Orthopedic · 90d
Cleared Sep 30, 2025
Francisella tularensis Real-time PCR assay
K252072 · SGA
Centers For Disease Control and...
Microbiology · 91d
Cleared Sep 30, 2025
Mobility Scooter (BBR-Q40-01)
K251799 · INI
Jiangsu Bangbang Intelligent...
Physical Medicine · 110d
Cleared Sep 30, 2025
Arthrex SpeedFLEX™ Implant
K251690 · OWY
Arthrex, Inc.
Orthopedic · 120d
Cleared Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669 · DSA
Shanghai Draeger Medical Instrument...
Cardiovascular · 123d
Cleared Sep 30, 2025
Dexter L6 System
K251197 · SDD
Distalmotion SA
General & Plastic Surgery · 166d
Cleared Sep 30, 2025
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · IYO
Astrasono Technology Co., Ltd.
Radiology · 237d
Cleared Sep 30, 2025
miDiagnostics HSV-1&2 CSF Test
K250050 · PGH
Midiagnostics NV
Microbiology · 263d
Cleared Sep 30, 2025
TigerConnect Alarm Management
K243270 · MSX
Tigerconnect
Cardiovascular · 349d
Cleared Sep 29, 2025
G-BLOCK
K253236 · EBF
Graphenano Dental S.L.
Dental
Cleared Sep 29, 2025
iLet ACE Pump
K252770 · QFG
Beta Bionics, Inc.
Chemistry · 27d
Cleared Sep 29, 2025
UltraGuideCTR® image guided soft tissue release system
K252594 · HRX
Sonex Health
Orthopedic · 45d
Cleared Sep 29, 2025
Primero Safe Access System
K252441 · DYB
South53, LLC
Cardiovascular · 56d
Cleared Sep 29, 2025
SpineAR SNAP (SyncAR Spine)
K252054 · SBF
Surgical Theater, Inc.
Orthopedic · 90d
Cleared Sep 29, 2025
allay Nerve Cap (TL5515-1)
K252051 · SBG
Tulavi Therapeutics, Inc.
Neurology · 90d
Cleared Sep 29, 2025
NEW DOUBLO 2.0
K251334 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 152d
Cleared Sep 29, 2025
SureTome™ SW Sphincterotome with DomeTip
K251104 · KNS
Wilson Cook Medical
Gastroenterology & Urology · 171d
Cleared Sep 29, 2025
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
K250123 · DZL
Hager& Meisinger GmbH
Dental · 255d
Cleared Sep 29, 2025
SMART PCFD
K250023 · QIH
Disior, Ltd.
Radiology · 269d
Cleared Sep 29, 2025
Paltop Dental Implant System
K243983 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 280d