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
10057–10080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2023
uMR 570
K230758 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared May 18, 2023
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
K230723 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 63d
Cleared May 18, 2023
ComASP Cefiderocol 0.008-128
K230479 · JWY
Liofilchem S. R. L.
Microbiology · 85d
Cleared May 18, 2023
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging...
K230453 · OBJ
Boston Scientific Corporation
Cardiovascular · 86d
Cleared May 18, 2023
Single Use Bipolar Forceps
K230432 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 90d
Cleared May 18, 2023
Single-Use Flexible Ureteroscope
K230200 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 113d
Cleared May 18, 2023
Restrata® MiniMatrix
K223725 · QSZ
Acera Surgical, Inc.
General & Plastic Surgery · 156d
Cleared May 18, 2023
I.V. Administration Set, I.V. Extension Set
K223645 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 163d
Cleared May 18, 2023
Anchor Bolts as Accessories to Depth Electrodes
K223276 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared May 18, 2023
Spencer Probe Depth Electrodes
K223269 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared May 18, 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · KKX
3M Company
General Hospital · 266d
Cleared May 18, 2023
Claritag Advanced
K222356 · GEH
Dgi Technologies
General & Plastic Surgery · 287d
Cleared May 18, 2023
Endo Motor
K220829 · EKX
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 422d
Cleared May 17, 2023
JuggerKnot Soft Anchor
K231128 · MBI
Riverpoint Medical, LLC
Orthopedic · 27d
Cleared May 17, 2023
Symbia Pro.specta VA20A Family
K231102 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared May 17, 2023
DeepX DermoSight Dermatoscope
K230448 · PSN
Deepx Health, LLC
General & Plastic Surgery · 85d
Cleared May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
K230286 · MXC
Abbott Medical
Cardiovascular · 104d
Cleared May 17, 2023
F&P Solo Mask Range
K223696 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 159d
Cleared May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with...
K223437 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 184d
Cleared May 17, 2023
Radiation Planning Assistant (RPA)
K222728 · MUJ
University of Texas, MD Anderson...
Radiology · 251d
Cleared May 16, 2023
SAVI Dual (TM) Migraine Therapy
K230358 · OKP
Eneura, Inc.
Neurology · 95d
Cleared May 16, 2023
BruxZir™ Incisal Coloring Liquid
K230262 · EIH
Prismatik Dentalcraft, Inc.
Dental · 105d
Cleared May 16, 2023
Eminent Spine 3D Lumbar Interbody Fusion Systems
K230219 · MAX
Eminent Spine, LLC
Orthopedic · 110d
Cleared May 16, 2023
Infrared Heat (Model: E0221)
K223893 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 139d