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
4369–4392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2025
PIVO™ Pro Needle-free Blood Collection Device
K241586 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 269d
Cleared Feb 27, 2025
Gelweave™ Vascular Prostheses
K241550 · DSY
Vascutek, Ltd.
Cardiovascular · 272d
Cleared Feb 26, 2025
BonVie+
K250346 · MQV
Elute, Inc.
Orthopedic · 20d
Cleared Feb 26, 2025
DEKA LOTUS
K250281 · ONF
El.En S.P.A.
General & Plastic Surgery · 26d
Cleared Feb 26, 2025
Aventus Thrombectomy System
K250202 · QEW
Inquis Medical
Cardiovascular · 33d
Cleared Feb 26, 2025
Millipede 070 Aspiration Catheter
K250012 · NRY
Perfuze, Ltd.
Neurology · 55d
Cleared Feb 26, 2025
Heel Incision Safety Lancet (SteriHeel 2)
K244036 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 58d
Cleared Feb 26, 2025
Disposable Blood Lancet (Soft Pro)
K244031 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 58d
Cleared Feb 26, 2025
Vasoview Hemopro 3 Power Supply
K243918 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 68d
Cleared Feb 26, 2025
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · FYA
Medline Industries, LP
General Hospital · 159d
Cleared Feb 26, 2025
pilot TLS
K241587 · LJS
Vygon Corporation
Cardiovascular · 268d
Cleared Feb 26, 2025
Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i)
K241576 · OGZ
Infraredx, Inc.
Cardiovascular · 268d
Cleared Feb 26, 2025
aiCockpit AI Viewer
K241546 · LLZ
Fovia, Inc.
Radiology · 271d
Cleared Feb 26, 2025
Ventripoint Medical System Plus (VMS+) 4.0
K241222 · QIH
Ventripoint Diagnostics , Ltd.
Radiology · 301d
Cleared Feb 25, 2025
JLK-AILink
K250348 · LLZ
JLK, Inc.
Radiology · 19d
Cleared Feb 25, 2025
WasherCap™ Fixation System
K250238 · MBI
Abanza Tecnomed S.L
Orthopedic · 29d
Cleared Feb 25, 2025
BruxZir® Esthetic NOW
K250223 · EIH
Prismatik Dentalcraft, Inc.
Dental · 29d
Cleared Feb 25, 2025
3DXR
K243446 · OWB
GE Medical Systems SCS
Radiology · 111d
Cleared Feb 25, 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 132d
Cleared Feb 25, 2025
Loss of Pulse Detection
K242967 · SDY
Fitbit
Cardiovascular · 152d
Cleared Feb 25, 2025
ART-Plan+ (v.3.0.0)
K242822 · MUJ
Therapanacea Sas
Radiology · 160d
Cleared Feb 25, 2025
EMS (FlexPulse, MagnaCore, Magnetika)
K241601 · NGX
Cpmt Laser (Canadian Pioneer Medical...
Physical Medicine · 266d
Cleared Feb 25, 2025
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
K233963 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 438d
Cleared Feb 24, 2025
ExamVue Apex
K244010 · MQB
Jpi Healthcare Co, Ltd.
Radiology · 60d