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
7201–7224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2024
Alinity m HSV 1 & 2 / VZV
K233349 · PGI
Abbott Molecular, Inc.
Microbiology · 217d
Cleared May 03, 2024
VaporMAX LDD
K233157 · GEX
Innovaquartz, LLC
General & Plastic Surgery · 219d
Cleared May 03, 2024
Megaloop Button System
K232941 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 226d
Cleared May 03, 2024
B-Ultrasound Diagnostic System
K232895 · IYO
Contec Medical Systems Co.,Ltd
Radiology · 228d
Cleared May 03, 2024
Tablo® Hemodialysis System
K232776 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 235d
Cleared May 03, 2024
EMA 3D
K232735 · LRK
Ema Sleep Incorporated
Dental · 239d
Cleared May 03, 2024
Mbrace Cable
K232733 · JDQ
Medacta International S.A.
Orthopedic · 239d
Cleared May 03, 2024
RODEO Telescopic Nail
K232648 · HSB
Orthofix Srl
Orthopedic · 246d
Cleared May 03, 2024
CT 5300
K232491 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 260d
Cleared May 03, 2024
Viral Transport Media (VTM)
K232454 · JSM
Alb Luz
Microbiology · 263d
Cleared May 03, 2024
AUTION EYE AI-4510 Urine Particle Analysis System
K232416 · LKM
Arkray, Inc.
Immunology · 266d
Cleared May 02, 2024
HemoScreen Hematology Analyzer
K240636 · GKZ
Pixcell Medical Technologies
Hematology · 57d
Cleared May 02, 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261 · KRD
Merit Medical Systems, Inc.
Cardiovascular · 92d
Cleared May 02, 2024
Revi™ System
K240037 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 118d
Cleared May 02, 2024
Mobility Scooter (W3431)
K240012 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 121d
Cleared May 02, 2024
Neodent Implant System – Custom Abutments
K233857 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 149d
Cleared May 02, 2024
Dragonfly™ Pancreaticobiliary Scope
K233752 · FBN
CenterPoint Systems, LLC
Gastroenterology & Urology · 162d
Cleared May 02, 2024
Hope&Her Vaginal Dilators
K233689 · HDX
Lujena, Inc.
Obstetrics & Gynecology · 167d
Cleared May 02, 2024
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler...
K232908 · IYN
Contec Medical Systems Co.,Ltd
Radiology · 226d
Cleared May 02, 2024
EVA15 insufflator
K232902 · HIF
Palliare , Ltd.
Obstetrics & Gynecology · 227d
Cleared May 02, 2024
VereSee Optical Veres Needle System
K232464 · HIF
Freyja Healthcare, LLC
Obstetrics & Gynecology · 261d
Cleared May 02, 2024
CSF-4 (CSF-4)
K232445 · DPS
Cardiacsense
Cardiovascular · 262d
Cleared May 01, 2024
Cold Compression
K240986 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 21d
Cleared May 01, 2024
DuraGraft Vascular Conduit Solution
K240925 · QEJ
Marizyme
Gastroenterology & Urology · 27d