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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54529–54552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2009
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
K082710 · KNT
Neochild, LLC
Gastroenterology & Urology · 129d
Cleared Jan 23, 2009
ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK,...
K082810 · MAI
Arthrex, Inc.
Orthopedic · 121d
Cleared Jan 23, 2009
PASTURE, MODELS: F550, A520
K083176 · NZJ
Pasture Pharma Pte, Ltd.
General Hospital · 87d
Cleared Jan 23, 2009
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
K083470 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Jan 23, 2009
JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
K083489 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 59d
Cleared Jan 23, 2009
VALO, MODEL 5919
K083647 · EBZ
Ultradent Products, Inc.
Dental · 45d
Cleared Jan 23, 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · KRH
St Jude Medical
Cardiovascular · 31d
Cleared Jan 23, 2009
AIRSTRIP OB
K090061 · HGM
Airstrip Technologies, LP
Obstetrics & Gynecology · 14d
Cleared Jan 22, 2009
CFS FLEXIBLE
K081537 · EBI
Comfort and Flexible Systems
Dental · 234d
Cleared Jan 22, 2009
IMAGE STORAGE SYSTEM, MODEL KSS-400
K081797 · NFJ
Konan Medical, Inc.
Ophthalmic · 211d
Cleared Jan 22, 2009
ENDEARE BREAST PUMP
K081932 · HGX
Hygeia Medical, Inc.
Obstetrics & Gynecology · 199d
Cleared Jan 22, 2009
SYRINGE WITH HANDI-FIL
K082212 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 169d
Cleared Jan 22, 2009
MERCURY SPINAL SYSTEM
K082353 · NKB
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Jan 22, 2009
EXTREMITY MEDICAL SUTURE ANCHOR
K083151 · MBI
Extremity Medical, LLC
Orthopedic · 90d
Cleared Jan 22, 2009
RAYAUTOPLAN 1.0
K083264 · MUJ
Raysearch Laboratories AB
Radiology · 78d
Cleared Jan 22, 2009
CLEAR BRAVO
K083473 · EBC
Denali R&D Corporation
Dental · 59d
Cleared Jan 22, 2009
RADPRO ION
K083725 · OWB
Virtual Imaging, Inc.
Radiology · 38d
Cleared Jan 22, 2009
LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
K083826 · MNH
Allez Spine, LLC
Orthopedic · 30d
Cleared Jan 22, 2009
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS:...
K083856 · GEI
Relievant Medsystems, Inc.
General & Plastic Surgery · 29d
Cleared Jan 22, 2009
PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S)...
K090044 · IYE
Oncolog Medical QA AB
Radiology · 15d
Cleared Jan 21, 2009
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
K080921 · BZG
Chest M.I., Inc.
Anesthesiology · 295d
Cleared Jan 21, 2009
CARE3 PLUS
K081811 · EFB
Nakanishi, Inc.
Dental · 209d
Cleared Jan 21, 2009
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
K081822 · JPK
Beckman Coulter, Inc.
Hematology · 208d
Cleared Jan 21, 2009
SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083,...
K082409 · GEX
Endophotonix, Inc.
General & Plastic Surgery · 153d