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
4801–4824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2025
Mobility Scooter (YL-09B, YL-07)
K242139 · INI
Yongkang Yile Vehicle Co., Ltd.
Neurology · 168d
Cleared Jan 06, 2025
Brainomix 360 e-CTA
K242123 · LLZ
Brainomix Limited
Radiology · 171d
Cleared Jan 06, 2025
DermiSphere Dermal Template
K241904 · KGN
Fesariustherapeutics, Inc.
General & Plastic Surgery · 189d
Cleared Jan 03, 2025
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™...
K250015 · DYH
Ormco Corporation
Dental · 1d
Cleared Jan 03, 2025
Inbella RF System
K243737 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 30d
Cleared Jan 03, 2025
JLK-ICH
K243363 · QAS
JLK, Inc.
Radiology · 66d
Cleared Jan 03, 2025
Synapsys VHIT
K242726 · GWN
Inventis S.R.L.
Ear, Nose, Throat · 115d
Cleared Jan 03, 2025
EVOLVE Nitric Oxide Delivery System
K242578 · MRN
Mallinckrodt Manufacturing, LLC
Anesthesiology · 127d
Cleared Jan 03, 2025
INNOVISION-EXII
K242119 · KPR
Dk Medical System
Radiology · 168d
Cleared Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · FDF
Pentax of America, Inc.
Gastroenterology & Urology · 168d
Cleared Jan 03, 2025
syngo.CT Dual Energy
K241757 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Jan 03, 2025
Clarify DL
K241350 · LLZ
Ge Medical Systems Israel, Functional...
Radiology · 235d
Cleared Jan 03, 2025
Elemental Granulate
K241283 · OLR
Zinkh NV
Dental · 241d
Cleared Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · MMI
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Jan 03, 2025
NobelProcera Zirconia Implant Bridge
K240346 · NHA
Nobel Biocare AB
Dental · 333d
Cleared Jan 03, 2025
GBR System
K233419 · DZL
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 451d
Cleared Jan 03, 2025
DUET-V (Model: ESK-3261DV)
K233118 · GEI
Eunsung Global Corp
General & Plastic Surgery · 464d
Cleared Jan 02, 2025
Pulse Oximeter (FS20P)
K243049 · DQA
Hunan Accurate Bio-Medical Technology...
Anesthesiology · 97d
Cleared Jan 02, 2025
Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
K242789 · OHS
Dongguan Laiguang Electronic...
General & Plastic Surgery · 108d
Cleared Jan 02, 2025
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
K242448 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 139d
Cleared Jan 02, 2025
Ezra Flash
K242334 · QIH
Ezra Ai, Inc.
Radiology · 148d
Cleared Jan 02, 2025
Wave Electrode (AE02-60)
K242326 · GXY
Bionit Labs Srl
Neurology · 149d
Cleared Jan 02, 2025
Ortho AI
K241696 · QIH
Ortho Ai, LLC
Radiology · 204d
Cleared Jan 02, 2025
CrystLCare™ PRO Biorestorative, Fluoride-Plus
K241568 · LBH
GreenMark Biomedical, Inc.
Dental · 216d