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
4489–4512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2025
NAEOTOM Alpha.Peak/ NAEOTOM Alpha
K243523 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Feb 12, 2025
SubtleHD (1.x)
K243250 · QIH
Subtle Medical, Inc.
Radiology · 120d
Cleared Feb 12, 2025
Fecobionics Anorectal System
K242666 · KLA
Gi Bionics, LLC
Gastroenterology & Urology · 160d
Cleared Feb 12, 2025
SureWave Elastography (Q7000225)
K242006 · LNH
Quality Electrodynamics, LLC
Radiology · 218d
Cleared Feb 12, 2025
Etiometry Platform (DAV 5.4 RAE 9.2)
K241479 · PPW
Etiometry, Inc.
Cardiovascular · 264d
Cleared Feb 12, 2025
AspenView
K241425 · LLZ
Aspen Imaging Healthcare, Inc.
Radiology · 268d
Cleared Feb 12, 2025
OptoMonitor 3
K241418 · DXO
Opsens, Inc.
Cardiovascular · 268d
Cleared Feb 11, 2025
InbellaBody System
K250200 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 19d
Cleared Feb 11, 2025
Vivid T9/Vivid T8
K243628 · IYN
GE Medical Systems Ultrasound and...
Radiology · 78d
Cleared Feb 11, 2025
Vivid iq
K243620 · IYN
GE Medical Systems Ultrasound and...
Radiology · 81d
Cleared Feb 11, 2025
BinaxNOW™ COVID-19 Antigen Self Test
K243518 · QYT
Abbott Diagnostics Scarborough, Inc.
Microbiology · 90d
Cleared Feb 11, 2025
NUVENTUS NV.C™ Surgical Cassette and Tray
K243317 · KCT
Infinitum Eta, Ltd.
General Hospital · 112d
Cleared Feb 11, 2025
CYLOX® ST
K243188 · OVE
Signus Medizintechnik GmbH
Orthopedic · 134d
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