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
4153–4176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2025
Alinity m BKV
K241921 · QMI
Abbott Molecular, Inc.
Microbiology · 266d
Cleared Mar 21, 2025
Natural Cycles
K250561 · PYT
Natural Cycles Nordic AB
Obstetrics & Gynecology · 24d
Cleared Mar 21, 2025
Porous Biologic Scaffold
K250556 · MQV
Ventris Medical
Orthopedic · 24d
Cleared Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
K250517 · FED
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Mar 21, 2025
IntelliSep Test (CV-ICG-048)
K250513 · QUT
Cytovale, Inc.
Microbiology · 28d
Cleared Mar 21, 2025
Catamaran SI Joint Fusion System
K250403 · OUR
Tenon Medical
Orthopedic · 37d
Cleared Mar 21, 2025
GoLIF! Lumbar Interbody Fusion System
K250186 · MAX
Getset Surgical, SA
Orthopedic · 58d
Cleared Mar 21, 2025
Signos Glucose Monitoring System
K250106 · SAF
Signos, Inc.
Chemistry · 65d
Cleared Mar 21, 2025
ARVIS Surgical Navigation System
K243980 · SBF
Kico Knee Innovation Company Pty Limited
Orthopedic · 88d
Cleared Mar 21, 2025
Consolidated Operating Room Equipment (CORE) 2 Console
K243958 · OLO
Stryker Instruments
Orthopedic · 88d
Cleared Mar 21, 2025
Rayvolve PTX-PE
K243808 · QFM
AZmed
Radiology · 100d
Cleared Mar 21, 2025
BD Vacutainer® Multiple Sample Luer Adapter
K243649 · JKA
Becton, Dickinson and Company
General Hospital · 115d
Cleared Mar 21, 2025
Medical Laser System Incanto / Evoline Platinum /Evoline
K243630 · GEX
Solar LS Cjsc
General & Plastic Surgery · 116d
Cleared Mar 21, 2025
FiAPC plus probes
K243451 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 134d
Cleared Mar 21, 2025
REMI Remote EEG Monitoring System
K243185 · OMC
Epitel
Neurology · 172d
Cleared Mar 21, 2025
EHL Probe (SCDG-AS)
K243032 · FFK
Guangzhou Potent Medical Equipment...
Gastroenterology & Urology · 175d
Cleared Mar 21, 2025
FloTrac sensors
K242909 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 178d
Cleared Mar 21, 2025
Electrohydraulic Lithotriptor (TCS-B3-II)
K242888 · FFK
Guangzhou Potent Medical Equipment...
Gastroenterology & Urology · 179d
Cleared Mar 21, 2025
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell...
K242564 · KCT
Prismatik Dentalcraft, Inc.
General Hospital · 205d
Cleared Mar 21, 2025
Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior...
K242289 · QJP
Stryker Neurovascular
Neurology · 231d
Cleared Mar 21, 2025
CaseMONO™ Culture (CMON)
K242107 · MQL
Casebioscience, Inc.
Obstetrics & Gynecology · 246d
Cleared Mar 21, 2025
FX CorAL 40 (F00009214)
K242053 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 252d
Cleared Mar 21, 2025
Philips Holter Analysis System
K241890 · MLO
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 266d
Cleared Mar 21, 2025
V-GRAD
K241833 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 269d