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: 2026–2026 ×
1,642 results
1105–1128 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 11, 2026
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
K253185 · IZL
Carestream Health
Radiology · 166d
Cleared Mar 11, 2026
LUOFUCON® Antimicrobial Wound Gel
K252028 · FRO
Huizhou Foryou Medical Co., Ltd.
General & Plastic Surgery · 254d
Cleared Mar 11, 2026
Venous Return Cannulae
K250937 · DWF
LivaNova USA, Inc.
Cardiovascular · 348d
Cleared Mar 10, 2026
Varios Combi Pro2
K260773 · ELC
Nakanishi, Inc.
Dental · 1d
Cleared Mar 10, 2026
Gemini NOVA 810+980 Soft Tissue Laser
K260765 · NVK
Azena Medical, LLC
Dental · 1d
Cleared Mar 10, 2026
Sonosite iLOOK Ultrasound System
K260595 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 15d
Cleared Mar 10, 2026
DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
K254093
Synthes GmbH
Orthopedic · 81d
Cleared Mar 10, 2026
IPS e.max Zirconia
K253953 · EIH
Ivoclar Vivadent, Inc.
Dental · 90d
Cleared Mar 10, 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
K253584 · OWB
Canon Medical Systems Corporation
Radiology · 113d
Cleared Mar 10, 2026
Reselute Tibial Nail
K253517 · HSB
Reselute, Inc.
Orthopedic · 118d
Cleared Mar 10, 2026
myray ProXIma X6
K252353 · OAS
Cefla S.C.
Radiology · 224d
Cleared Mar 10, 2026
Straumann® BLC Implants - Indication Widening
K252168 · DZE
Institut Straumann AG
Dental · 243d
Cleared Mar 09, 2026
FiberTape Button
K260405 · MBI
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 09, 2026
Webest Multi-Drug Urine Cup
K260355 · NFT
WEBEST Biotech,, LLC
Toxicology · 34d
Cleared Mar 09, 2026
DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
K260069 · HRS
Synthes GmbH
Orthopedic · 59d
Cleared Mar 09, 2026
QIAstat-Dx Gastrointestinal Panel 2
K254032 · PCH
QIAGEN GmbH
Microbiology · 83d
Cleared Mar 09, 2026
Medicell Mycosis Laser (MCML24004)
K253960 · PDZ
Medicell Healthcare Co.,LTD
General & Plastic Surgery · 89d
Cleared Mar 09, 2026
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A,...
K253934 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 90d
Cleared Mar 09, 2026
LiverMultiScan (v6.0)
K253413 · LNH
Perspectum, Ltd.
Radiology · 159d
Cleared Mar 09, 2026
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
K253189 · MBH
Zimmer, Inc.
Orthopedic · 164d
Cleared Mar 09, 2026
NeoSculpt Plus
K252888 · PBX
S&M Medical Co., Ltd.
General & Plastic Surgery · 180d
Cleared Mar 09, 2026
FUJIFILM Endoscope Model ED-S100TP
K251861 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 265d
Cleared Mar 08, 2026
Onera SleepMap (SLEEPMAP)
K253668 · OLZ
Onera B.V.
Neurology · 107d
Cleared Mar 06, 2026
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 30d