Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
33481–33504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2015
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
K150525 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 263d
Cleared Nov 20, 2015
3i T3 Short Implants
K150571 · DZE
Biomet 3i
Dental · 259d
Cleared Nov 20, 2015
Gemini Sterilization Wrap
K150698 · FRG
Medline Industries, Inc.
General Hospital · 247d
Cleared Nov 20, 2015
Collagen Dural Regeneration Matrix
K150825 · GXQ
Collagen Matrix, Inc.
Neurology · 238d
Cleared Nov 20, 2015
IQQA Guide
K151414 · JAK
Edda Technology
Radiology · 177d
Cleared Nov 20, 2015
BioArchitects Patient Specific Cranial/Craniofacial Plate
K151692 · GXN
Bioarchitects USA, LLC
Neurology · 150d
Cleared Nov 20, 2015
Single Use Aspiration Needle NA-U200H
K151738 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 147d
Cleared Nov 20, 2015
Libra Pedicle Screw System
K151770 · NKB
Spinal Balance, Inc.
Orthopedic · 143d
Cleared Nov 20, 2015
CONCORDE Bullet Lumbar Interbody System
K151773 · MAX
Medos International SARL
Orthopedic · 143d
Cleared Nov 20, 2015
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH...
K151792 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 142d
Cleared Nov 20, 2015
e-1 etchants
K152110 · KLE
E Dental Products
Dental · 114d
Cleared Nov 20, 2015
Cam Lock Plating System
K152282 · KWQ
Life Spine, Inc.
Orthopedic · 100d
Cleared Nov 20, 2015
XprESS Multi-Sinus Dilation System
K152434 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 20, 2015
PassAssist LED Light Fiber
K152435 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 20, 2015
Pi Drive Plus Motor, Extender
K152641 · ERL
Stryker Corporation
Ear, Nose, Throat · 66d
Cleared Nov 20, 2015
Parcus GFS Naked
K152711 · MBI
Parcus Medical, LLC
Orthopedic · 60d
Cleared Nov 20, 2015
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
K152713 · PGY
Eizo Corporation
Radiology · 60d
Cleared Nov 20, 2015
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis...
K152853 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 52d
Cleared Nov 20, 2015
RX ACCUNET Embolic Protection System
K153086 · NTE
Abbott Vascular
Cardiovascular · 25d
Cleared Nov 20, 2015
ProFlu+ Assay
K153219 · OCC
Hologic, Inc.
Microbiology · 15d
Cleared Nov 19, 2015
MoisturemeterD
K143310 · OBH
Delfin Technologies, Ltd.
Gastroenterology & Urology · 366d
Cleared Nov 19, 2015
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
K150094 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 307d
Cleared Nov 19, 2015
Gmate SMART Blood Glucose Monitoring System
K150299 · NBW
Philosys, Inc.
Chemistry · 286d
Cleared Nov 19, 2015
RT2 Trabeculite Titanium Cervical Cage System
K150455 · ODP
Rhausler, Inc.
Orthopedic · 272d