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
2041–2064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2025
KLS Martin IPS Forearm System
K250865 · HRS
KLS-Martin L.P.
Orthopedic · 238d
Cleared Nov 14, 2025
Second Opinion® Panoramic
K250525 · MYN
Pearl, Inc.
Radiology · 266d
Cleared Nov 14, 2025
System Sophi
K250501 · HQC
This AG
Ophthalmic · 267d
Cleared Nov 14, 2025
AquaC UNO H
K250471 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 269d
Cleared Nov 13, 2025
ACUSON Juniper Diagnostic Ultrasound System
K253457 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 38d
Cleared Nov 13, 2025
Geminus Volar Distal Radius Plating System
K252949 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 58d
Cleared Nov 13, 2025
TELLTALE Electrosurgical Guidewire System
K252592 · SGO
Telltale, LLC
Cardiovascular · 90d
Cleared Nov 13, 2025
LED Beauty Mask (RLBXX)
K252308 · OHS
Atop Lighting Co., Ltd.
General & Plastic Surgery · 112d
Cleared Nov 13, 2025
Dental Computed Tomography X-ray System
K251842 · OAS
Fussen Technology Co., Ltd.
Radiology · 150d
Cleared Nov 13, 2025
Air Compression Therapy Device (ST-504)
K251662 · IRP
Shenzhen Future Electronic Co., Ltd.
Physical Medicine · 167d
Cleared Nov 13, 2025
Rosa® Knee System
K251314 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 199d
Cleared Nov 12, 2025
XSTAT P15
K253290 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 44d
Cleared Nov 12, 2025
WRISTAR MultiAx Distal Radius Kit
K252959 · HRS
Intrauma S.P.A
Orthopedic · 57d
Cleared Nov 12, 2025
Powered Wheelchair (PL001-9001)
K252829 · ITI
Suzhou KD Intelligent Device Co., Ltd.
Physical Medicine · 68d
Cleared Nov 12, 2025
PeekMed web
K252452 · QIH
Peek Health, S.A.
Radiology · 100d
Cleared Nov 12, 2025
CMORE® CT System
K252327 · NKG
Icotec AG
Orthopedic · 110d
Cleared Nov 12, 2025
Hemoclip
K252271 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 114d
Cleared Nov 12, 2025
EMPOWR Acetabular® Liner Extension
K251833 · LPH
Encore Medical, L.P.
Orthopedic · 149d
Cleared Nov 12, 2025
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)
K251336 · OWN
Olympus Medical Systems Corp.
General & Plastic Surgery · 196d
Cleared Nov 12, 2025
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical...
K243897 · NEW
Ethicon, Inc.
General & Plastic Surgery · 328d
Cleared Nov 12, 2025
Synthes Patient Specific Implants
K243715 · GXN
Synthes GmbH
Neurology · 345d
Cleared Nov 10, 2025
KLS Martin Cranial Implants - MR Conditional
K252573 · GXN
KLS-Martin L.P.
Neurology · 88d
Cleared Nov 10, 2025
EzSensor HD, EzSensor UHD
K252570 · MUH
Qpix Solutions, Inc.
Radiology · 88d
Cleared Nov 10, 2025
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
K252560 · PLR
Atlas Spine, Inc.
Orthopedic · 89d