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
11425–11448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2022
8ch Wrist Coil
K223239 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 49d
Cleared Dec 08, 2022
InkSpace Imaging Body Array
K223487 · MOS
Inkspace Imaging, Inc.
Radiology · 17d
Cleared Dec 07, 2022
PVC Hydrophilic Urethral Catheter
K212567 · EZD
Chengdu Daxan Innovative Medical...
Gastroenterology & Urology · 478d
Cleared Dec 07, 2022
Dexcom G7 Continuous Glucose Monitoring System
K213919 · QBJ
Dexcom, Inc.
Chemistry · 357d
Cleared Dec 07, 2022
HydroMID 4F Single Lumen Midline Catheter
K220772 · FOZ
Access Vascular, Inc.
General Hospital · 266d
Cleared Dec 07, 2022
OAKTREE Anterior Lumbar Plate and Screw System
K220843 · KWQ
Oak Tree Engineering, LLC
Orthopedic · 259d
Cleared Dec 07, 2022
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with...
K221626 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 184d
Cleared Dec 07, 2022
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836 · CAH
Dr?gerwerk AG & Co KGaA
General Hospital · 167d
Cleared Dec 07, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
K221842 · QSE
Roche Diagnostics
Immunology · 166d
Cleared Dec 07, 2022
Ultrasound System 2300
K222441 · IYN
Bk Medical Aps
Radiology · 117d
Cleared Dec 07, 2022
3-Ply Disposable Medical Mask
K223045 · FXX
Wealth Lead Industrial Limited
General Hospital · 69d
Cleared Dec 07, 2022
ViewFlex Xtra ICE Catheter
K223077 · OBJ
Irvine Biomedical, A St. Jude Medical...
Cardiovascular · 68d
Cleared Dec 07, 2022
Disposable Nitrile Examination Glove
K223281 · LZA
Anhui Kindguard Medical Supplies...
General Hospital · 43d
Cleared Dec 07, 2022
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K223394 · HQD
Visionary Optics, LLC
Ophthalmic · 29d
Cleared Dec 07, 2022
Cios Select (VA21) Flat Panel
K223410 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 06, 2022
Femoral Trochanteric Nail System – Neonail
K221021 · HSB
Neoortho Produtos Ortop?dicos S/A
Orthopedic · 244d
Cleared Dec 06, 2022
R2 Studio Q/RCT820
K222219 · OAS
Megagen Implant Co., Ltd.
Radiology · 134d
Cleared Dec 06, 2022
MedDream
K222320 · LLZ
Softneta Uab
Radiology · 126d
Cleared Dec 06, 2022
Bifurcated Needle
K222385 · SCL
Anhui Tiankang Medical Technology...
General Hospital · 120d
Cleared Dec 06, 2022
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 106d
Cleared Dec 06, 2022
HurriChem Device Kit
K222575 · GCJ
Thermasolutions, LLC
General & Plastic Surgery · 103d
Cleared Dec 06, 2022
Dental Zirconia Ceramic
K222626 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 97d
Cleared Dec 06, 2022
iCE-SG2 Subcutaneous Electrode Kit
K222706 · GZL
Ice Neurosystems, Inc.
Neurology · 90d
Cleared Dec 06, 2022
Swoop Portable MR Imaging System
K223247 · LNH
Hyperfine, Inc.
Radiology · 46d