FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49–72 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2026
Elos Accurate Hybrid Base
K261327 · NHA
Elos Medtech Pinol A/S
Dental · 161d
Cleared Sep 30, 2026
ECG Analysis Software (AiTiALVSD)
K254302 · QYE
Medical AI Co., Ltd.
Cardiovascular · 273d
Cleared Sep 29, 2026
Fast Absorbing PGLA
K263073 · GAM
Riverpoint Medical, LLC
General & Plastic Surgery · 28d
Cleared Sep 29, 2026
Syngo Carbon Space (VA4)
K263048 · LLZ
Siemens Healthineers AG
Radiology · 29d
Cleared Sep 29, 2026
NeckTune™ SA Cervical Cage
K262726 · OVE
Medyssey Co, Ltd.
Orthopedic · 60d
Cleared Sep 29, 2026
Spinalogic Bone Growth Stimulator
K262721 · LOF
Djo, LLC
Orthopedic · 60d
Cleared Sep 29, 2026
MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)
K262553 · INI
Zhejiang Kailang Technology Co., Ltd.
Physical Medicine · 67d
Cleared Sep 29, 2026
Electric Wheelchair (0080)
K262241 · ITI
Xuzhou Heabens Medical Technology...
Physical Medicine · 90d
Cleared Sep 29, 2026
Power Mobility Scooter (MA03)
K262213 · INI
Nanjing Mijo Technology Co., Ltd.
Physical Medicine · 91d
Cleared Sep 29, 2026
Elucid FFR-IQ (B.1)
K262015 · PJA
Elucid Bioimaging, Inc.
Cardiovascular · 106d
Cleared Sep 29, 2026
CAS-One IR
K261225 · JAK
Cascination AG
Radiology · 167d
Cleared Sep 29, 2026
QCA 10 Electrocardiograph (QCARD-10)
K260250 · DPS
QT Medical, Inc.
Cardiovascular · 245d
Cleared Sep 29, 2026
THERMEO® I MSI
K260031 · MQC
Pro3dure Medical GmbH
Dental · 266d
Cleared Sep 28, 2026
Alians Forearm
K262649 · HRS
Newclip Technics
Orthopedic · 60d
Cleared Sep 28, 2026
Tri Stage Venous Cannulae
K262052 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 102d
Cleared Sep 28, 2026
Phasix ST Parastomal Hernia Mesh
K261543 · OWT
Davol, Inc., A Subsidiary of C.R....
General & Plastic Surgery · 143d
Cleared Sep 28, 2026
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
K260619 · LON
Biom?rieux, Inc.
Microbiology · 215d
Cleared Sep 28, 2026
Liora Monofilament Scaffold
K260474 · FTL
TELA Bio, Inc.
General & Plastic Surgery · 228d
Cleared Sep 27, 2026
Ultima System (UL-800)
K260945
Fit-Pro KFT (Ltd.) - DBA E-Fit
Physical Medicine · 188d
Cleared Sep 27, 2026
Kentrospine Viktr-MIS® Pedicle screw system
K252139 · NKB
Rivarp Medical Pvt., Ltd.
Orthopedic · 446d
Cleared Sep 25, 2026
EVO X30 Diagnostic Ultrasound System
K263182 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Sep 25, 2026
EsTemp Implant
K262983 · EMA
Spident Co., Ltd.
Dental · 29d
Cleared Sep 25, 2026
Arthrex Beaming System
K262975 · HWC
Arthrex, Inc.
Orthopedic · 30d
Cleared Sep 25, 2026
EPIQ Inspira Series Diagnostic Ultrasound System
K262548 · IYN
Philips Ultrasound, LLC
Radiology · 64d