FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
745–768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2026
SmartClip Delivery Catheter (ADR-1715)
K260565 · EOQ
Elucent Medical
Anesthesiology · 84d
Cleared May 14, 2026
Any-Etch
K260485 · KLE
Mediclus Co., Ltd.
Dental · 90d
Cleared May 14, 2026
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
K260111 · IYN
Mytech Intelligence (Shenzhen) Co., Ltd.
Radiology · 120d
Cleared May 14, 2026
RAYMO Mobile X-ray System (Model: RAYMO)
K260085 · IZL
DRGEM Corporation
Radiology · 122d
Cleared May 14, 2026
ENTity USB Videoscope System
K254133 · EOB
Optim, LLC
Ear, Nose, Throat · 143d
Cleared May 14, 2026
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M,...
K254048 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 148d
Cleared May 14, 2026
SubtleHD-PET (1.x)
K254013 · LLZ
Subtle Medical, Inc.
Radiology · 150d
Cleared May 14, 2026
Bonalive Maxillofacial
K253883 · LYC
Bonalive , Ltd.
Dental · 161d
Cleared May 14, 2026
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
K253676 · MRW
Providence Medical Technology, Inc.
Orthopedic · 174d
Cleared May 14, 2026
ET Healing Abutments
K253372 · NHA
Hiossen, Inc.
Dental · 226d
Cleared May 14, 2026
ART.1-US
K253078 · MUJ
Seetreat Pty, Ltd.
Radiology · 233d
Cleared May 14, 2026
ARIES Anterior Cervical Plate Systems
K252776 · KWQ
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 254d
Cleared May 14, 2026
Disposable Syringes with Accessories for Power Injectors (900103T)
K252652 · DXT
Fortis Biosolutions Company Limited
General Hospital · 265d
Cleared May 14, 2026
Pelvic Muscle Trainer (PC22A)
K252601 · KPI
Hunan Accurate Bio-Medical Technology...
Gastroenterology & Urology · 269d
Cleared May 13, 2026
Y-Knotless™ Flex Anchors
K261363 · MBI
Conmed Corporation
Orthopedic · 16d
Cleared May 13, 2026
Morph
K260032 · QIH
BeauBrain Healthcare, Inc.
Radiology · 127d
Cleared May 13, 2026
Electric Breast Pump (HL-3058 II Pro)
K254125 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 145d
Cleared May 13, 2026
StatSeal Disc
K254073 · FRO
Merit Medical Systems, Inc.
General & Plastic Surgery · 146d
Cleared May 13, 2026
Electric Wheelchair (Y207BL)
K253241 · ITI
Jiangsu Intco Medical Products Co., Ltd.
Physical Medicine · 226d
Cleared May 13, 2026
SURGIMAGE SIM 1000H Fluorescence Imaging Platform
K253181 · IZI
Surgimage Corporation
General & Plastic Surgery · 229d
Cleared May 13, 2026
Portable Neuromodulation Stimulator (PoNS)
K253061 · QCF
Helius Medical, Inc.
Neurology · 233d
Cleared May 13, 2026
ACIST Pro Diagnostic System (019304)
K252653 · DXT
Acist Medical Systems, Inc.
General Hospital · 264d
Cleared May 13, 2026
VeraPro S100 Multi-Use Syringe (018808)
K252638 · DXT
Acist Medical Systems, Inc.
General Hospital · 266d
Cleared May 13, 2026
Automatic Micro Needle System (CODE-X)
K252591 · QAI
Woorhi Mechatronics Co., Ltd.
General & Plastic Surgery · 271d