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
4753–4776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2025
Ampa One System (AMPA-001)
K243319 · OBP
Neuromodulatory Devices & Applications
Neurology · 113d
Cleared Feb 13, 2025
Integrated Endo System (Meet Endo-II)
K242317 · ELC
Denjoy Dental Co., Ltd.
Dental · 192d
Cleared Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
K242104 · NRY
Penumbra, Inc.
Neurology · 210d
Cleared Feb 13, 2025
Unicorn+ RF System (Unicorn+)
K241832 · GEI
Boston Aesthetics, Inc.
General & Plastic Surgery · 233d
Cleared Feb 13, 2025
Freedom® Total Knee System - Porous Tibial Base Plate
K241597 · MBH
Maxx Orthopedics, Inc.
Orthopedic · 255d
Cleared Feb 13, 2025
EDEN ControlCath
K241410 · BSO
Jmt Co., Ltd.
Anesthesiology · 272d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243962 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243961 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
Affixus Tibial Nailing System - 4mm screws
K243907 · HSB
Zimmer, Inc.
Orthopedic · 55d
Cleared Feb 12, 2025
V8 Diagnostic Ultrasound System
K243702 · IYN
Samsung Medison Co., Ltd.
Radiology · 75d
Cleared Feb 12, 2025
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG...
K243575 · MYF
Biokit, S.A.
Microbiology · 85d
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