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
2593–2616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2025
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
K251826 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Sep 11, 2025
Serafin®
K251758 · NXC
Tns Co., Ltd.
Dental · 94d
Cleared Sep 11, 2025
SIGNA™ Sprint
K251399 · LNH
Ge Medical Systems, LLC
Radiology · 128d
Cleared Sep 11, 2025
XTRA4
K251320 · LYX
Al.Chi.Mi.A. S.R.L
Ophthalmic · 135d
Cleared Sep 11, 2025
Mazor X System / Mazor X Stealth Edition
K251316 · OLO
Mazor Robotics , Ltd.
Orthopedic · 135d
Cleared Sep 11, 2025
PowerWire® 14 Radiofrequency Guidewire Kit
K251158 · PDU
Baylis Medical Technologies, Inc.
Cardiovascular · 149d
Cleared Sep 11, 2025
UV5000 Handle
K250797 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 181d
Cleared Sep 11, 2025
Hypertension Notification Feature (HTNF)
K250507 · SFR
Apple, Inc.
Cardiovascular · 202d
Cleared Sep 11, 2025
OsteoProbe (OP-100)
K250216 · QGQ
Active Life Scientific, Inc.
Orthopedic · 230d
Cleared Sep 11, 2025
Vivatmo pro-S
K243926 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 265d
Cleared Sep 11, 2025
Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
K242314 · LLZ
Augment Intelligent Medical System...
Radiology · 402d
Cleared Sep 10, 2025
iQ200 Series
K252580 · LKM
Beckman Coulter, Inc.
Hematology · 26d
Cleared Sep 10, 2025
OptiVu™ Shoulder
K252530 · SBF
Mr Surgical Solutions, LLC
Orthopedic · 30d
Cleared Sep 10, 2025
Surfacer Inside-Out Access Catheter System
K252527 · QJH
Merit Medical System, Inc.
Cardiovascular · 30d
Cleared Sep 10, 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb...
K252173 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 61d
Cleared Sep 10, 2025
da Vinci SP Surgical System (SP1098)
K251817 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Sep 10, 2025
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
K251573 · LPL
Vizionfocus, Inc.
Ophthalmic · 111d
Cleared Sep 10, 2025
OptiLUV Device
K250734 · PBX
Pollogen, Ltd.
General & Plastic Surgery · 183d
Cleared Sep 10, 2025
Enlight 2100 (TPL-E2103-0)
K250464 · QEB
Timpel S.A.
Anesthesiology · 204d
Cleared Sep 10, 2025
AngioWaveNet
K244002 · QIH
Angiowave Imaging, Inc.
Radiology · 258d
Cleared Sep 09, 2025
AI-Rad Companion Prostate MR
K252608 · LLZ
Siemens Healthcare GmbH
Radiology · 22d
Cleared Sep 09, 2025
Quadsense (Quadsense and Quadsense Pro)
K252524 · ONN
Eventum Orthopaedics, Ltd.
Orthopedic · 29d
Cleared Sep 09, 2025
Hybrid Viewer (00859873006240)
K252477 · KPS
Hermes Medical Solutions AB
Radiology · 33d
Cleared Sep 09, 2025
AquaA
K252181 · FIP
Fresenius Medical Care North America
Gastroenterology & Urology · 60d