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
337–360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2026
Manual Wheelchair (MS01)
K261075 · IOR
GuangDong Yong Yi Rehabilitation...
Physical Medicine · 82d
Cleared Jun 22, 2026
CMN Capillary Function with Oncology Virtual Expert
K260316
Cercare Medical A/S
Radiology · 143d
Cleared Jun 22, 2026
Medline Reusable Blood Pressure Cuff
K254287 · DXQ
Medline Industries, LP
Cardiovascular · 173d
Cleared Jun 22, 2026
Flow Water-Based Personal Lubricant
K254011 · NUC
LBDO Group, Inc.
Obstetrics & Gynecology · 189d
Cleared Jun 22, 2026
Perfusion Measurement Platform v1
K253421 · LLZ
Quantified Imaging Limited
Radiology · 264d
Cleared Jun 22, 2026
TearView
K253176 · HKI
Beyond 700 Pty, Ltd.
Ophthalmic · 269d
Cleared Jun 22, 2026
RX-1 Sleep
K253148 · MNR
Vivaquant, Inc. Dba Rhythm Express
Anesthesiology · 270d
Cleared Jun 20, 2026
Dynamis Robotic Surgical System
K260369 · OLO
LEM Surgical AG
Orthopedic · 135d
Cleared Jun 18, 2026
Synapse PACS (7.6.0)
K261713 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 27d
Cleared Jun 18, 2026
MEMO 4D Curve™ Semirigid mitral annuloplasty ring
K261707 · KRH
Corcym S.r.l.
Cardiovascular · 27d
Cleared Jun 18, 2026
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
K261701 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 27d
Cleared Jun 18, 2026
CORUS™ Navigation System-GN
K261665 · OLO
Providence Medical Technology, Inc.
Orthopedic · 29d
Cleared Jun 18, 2026
Precice™ Max System and Precice™ Ankle Salvage System
K261651 · HSB
NuVasive Specialized Orthopedics
Orthopedic · 30d
Cleared Jun 18, 2026
SRGC-06
K261246 · EBF
GC America, Inc.
Dental · 63d
Cleared Jun 18, 2026
Blood Volume Analyzer (200)
K261099 · JWO
Daxor Corporation
Hematology · 77d
Cleared Jun 18, 2026
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
K260946 · OHS
Guangdong Newdermo Biotech Co., Ltd.
General & Plastic Surgery · 87d
Cleared Jun 18, 2026
VIVIX-S 4386W (FXRD-4386WA)
K260820 · MQB
Vieworks Co., Ltd.
Radiology · 97d
Cleared Jun 18, 2026
Vascular Assist Occlusion Triage (VAOT) (v1.0)
K260729 · QAS
GuideAI Health
Radiology · 104d
Cleared Jun 18, 2026
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
K260636 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 112d
Cleared Jun 18, 2026
NOVEOS Specific IgE (sIgE)
K260280 · DHB
Hycor Biomedical
Immunology · 140d
Cleared Jun 18, 2026
ARTHUR
K260190 · IYO
ROPCA ApS
Radiology · 147d
Cleared Jun 18, 2026
Pelvic Muscle Trainer (KM510, KM516B)
K260178 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 148d
Cleared Jun 18, 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
K254254 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 171d
Cleared Jun 18, 2026
SmartSpectra Vital Signs Monitor 1.0
K254169 · QME
Presage Security, Inc. d/b/a Presage...
Cardiovascular · 177d