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
1225–1248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2026
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set...
K260043 · DWF
Smart Reactors
Cardiovascular · 47d
Cleared Feb 23, 2026
IPL Hair Removal Device (Models: T31A, T32A)
K253666 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 94d
Cleared Feb 23, 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal...
K253648 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 95d
Cleared Feb 23, 2026
Mobility Scooter (CL-Q3, CL-Q4)
K253631 · INI
Zhejiang Wei Ling New Energy...
Physical Medicine · 96d
Cleared Feb 23, 2026
LUX Expandable Lumbar Interbody System
K253583 · MAX
Xenix Medical
Orthopedic · 98d
Cleared Feb 23, 2026
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)
K253531 · KGW
Applied Medical Resources Corporation
General & Plastic Surgery · 102d
Cleared Feb 23, 2026
SKIA-Head (Model: SKIA-ST00)
K253486 · LLZ
Skia, Inc.
Radiology · 129d
Cleared Feb 23, 2026
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
K253244 · IZL
Poskom Co., Ltd.
Radiology · 147d
Cleared Feb 23, 2026
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
K253228 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 147d
Cleared Feb 23, 2026
Duet™ Spinal Fixation System
K253169 · NKB
Box Spine, LLC
Orthopedic · 150d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068 · FMF
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Feb 23, 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy...
K252795 · KNW
Argon Medical Devices, Inc.
General & Plastic Surgery · 174d
Cleared Feb 23, 2026
Rubber Utility Catheter
K251864 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 251d
Cleared Feb 23, 2026
Mariana Minerva
K251661 · MNS
Resmed Pty , Ltd.
Anesthesiology · 269d
Cleared Feb 23, 2026
VITA VMLC Primer
K251587 · KLE
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Dental · 276d
Cleared Feb 22, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d
Cleared Feb 21, 2026
Advanced Tissue Resection Device
K251692 · FDI
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Feb 20, 2026
LF Process Indicator Tape for Steam Sterilization
K260181 · JOJ
Intertape Polymer Group
General Hospital · 30d
Cleared Feb 20, 2026
KLS Martin Ixos System
K254162 · HRS
KLS-Martin L.P.
Orthopedic · 60d
Cleared Feb 20, 2026
FAQ™ (LED Panel)
K253683 · OHS
Foreo, Inc.
General & Plastic Surgery · 91d
Cleared Feb 20, 2026
KLS Martin Pure Pectus System
K253660 · HRS
KLS-Martin L.P.
Orthopedic · 92d
Cleared Feb 20, 2026
Xpert Hemorrhagic Fever
K253653
Cepheid
Microbiology · 92d
Cleared Feb 20, 2026
Safety Heel Lancet
K253605 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 94d
Cleared Feb 20, 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445 · FQH
Bd
General & Plastic Surgery · 141d