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
3793–3816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2025
Disposable Biopsy Forceps (FB-211D)
K250957 · EOQ
Olympus Medical Systems Corporation
Anesthesiology · 60d
Cleared May 30, 2025
VCFix Spinal System
K250637 · NDN
Amber Implants
Orthopedic · 88d
Cleared May 30, 2025
KALA Red Light Face Mask (KALA-01)
K250581 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 92d
Cleared May 30, 2025
Wearable Breast Pump (Model S21)
K250368 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared May 30, 2025
Motif Aura Glow breast pump (Model Motif Aura Glow)
K250365 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared May 30, 2025
EsFlow PLUS
K250317 · EBF
Spident Co., Ltd.
Dental · 115d
Cleared May 30, 2025
Swoop® Portable MR Imaging® System (V2)
K250236 · LNH
Hyperfine, Inc.
Radiology · 123d
Cleared May 30, 2025
MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
K250195 · GEX
Matelaser, Inc.
General & Plastic Surgery · 127d
Cleared May 30, 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
K250150 · DTR
Sorin Group Italia S.R.L.
Cardiovascular · 129d
Cleared May 30, 2025
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078 · QME
Mindset Medical, Inc.
Cardiovascular · 137d
Cleared May 30, 2025
TE Air Diagnostic Ultrasound System
K250024 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 144d
Cleared May 30, 2025
Opulus™ Lymphoma Precision
K243863 · QIH
Roche Molecular Systems, Inc.
Radiology · 164d
Cleared May 30, 2025
DentalJect
K243654 · MLY
Vapocoolshot, Inc.
Dental · 185d
Cleared May 30, 2025
Dynamic TiBase
K243530 · NHA
Talladium Espa?a, SL
Dental · 197d
Cleared May 30, 2025
ViVi® Toga Premium
K243522 · FYA
Thi Total Healthcare Innovation GmbH
General Hospital · 197d
Cleared May 30, 2025
5008X Hemodialysis System
K243505 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 199d
Cleared May 30, 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 246d
Cleared May 30, 2025
AudaxCeph Cephalogram Analysis Software
K243005 · QIH
Audax D.O.O.
Radiology · 246d
Cleared May 30, 2025
XBody Go USA, XBody Pro USA
K242926 · NGX
Xbody Hungary Kft.
Physical Medicine · 248d
Cleared May 30, 2025
LensHooke X3 PRO Semen Quality Analyzer
K242830 · POV
Bonraybio Co., Ltd.
Hematology · 253d
Cleared May 30, 2025
ARIX Pectus Bar System
K242751 · HRS
Jeil Medical Corporation
Orthopedic · 260d
Cleared May 30, 2025
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and...
K242725 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 262d
Cleared May 30, 2025
FertiCult Flushing medium
K242640 · MQL
Fertipro NV
Obstetrics & Gynecology · 269d
Cleared May 30, 2025
Endoscopic Distal Attachment (AF-D series)
K242635 · FDS
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 269d