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
1081–1104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2026
Tyto Stethoscope (G3)
K252089 · DQD
Tyto Care , Ltd.
Cardiovascular · 253d
Cleared Mar 12, 2026
Mimics Thoracic Planner
K251964 · LLZ
Materialise NV
Radiology · 259d
Cleared Mar 12, 2026
VPAP Pediatric Face Mask
K251888 · CBK
Hsiner Co., Ltd.
Anesthesiology · 265d
Cleared Mar 12, 2026
Trax EX Anchor
K251750 · MBI
Trax Surgical, Inc.
Orthopedic · 276d
Cleared Mar 12, 2026
Medical Mesh Nebulizer (AirICU Max+)
K251584 · SFP
AIRICU, Inc.
Anesthesiology · 293d
Cleared Mar 12, 2026
InVera Infusion Device
K250794 · KRA
Invera Medical
Cardiovascular · 363d
Cleared Mar 12, 2026
Deep Capsule® (Deep Capsule US)
K250655 · QZF
Digestaid - Artificial Intelligence...
Gastroenterology & Urology · 372d
Cleared Mar 12, 2026
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
K240934 · DTZ
Spectrum Medical S.R.L.
Cardiovascular · 706d
Cleared Mar 11, 2026
Venus Diamond
K260783 · EBF
Kulzer, LLC
Dental · 1d
Cleared Mar 11, 2026
Picasso Pro Diode Laser (002-00460)
K254197 · GEX
CAO Group, Inc.
General & Plastic Surgery · 78d
Cleared Mar 11, 2026
Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05,...
K254047 · OHT
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 84d
Cleared Mar 11, 2026
da Vinci Force Feedback Instruments
K253986 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 11, 2026
Xpert Hand
K253906 · HRS
Newclip Technics
Orthopedic · 96d
Cleared Mar 11, 2026
Strut Suture
K253693 · MBI
Riverpoint Medical, LLC
Orthopedic · 110d
Cleared Mar 11, 2026
INHANCE™ Reverse Shoulder System
K253624 · PHX
Depuy Ireland UC
Orthopedic · 113d
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