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

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175,820 results
36097–36120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2015
Headless Compression Screw System
K143624 · HWC
Skeletal Dynamics, LLC
Orthopedic · 22d
Cleared Jan 12, 2015
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
K140984 · FIN
Tango3, LLC
Gastroenterology & Urology · 271d
Cleared CT Jan 12, 2015
Intelliwave4
K142641 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 117d
Cleared Jan 12, 2015
DacryoCATH
K142914 · OKS
Armadillo Biomedical, LLC
Ophthalmic · 97d
Cleared Jan 12, 2015
CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT
K143223 · JAK
Toshibamedical Systems Corporation
Radiology · 63d
Cleared Jan 12, 2015
Presto Inflation Device
K143522 · MAV
C.R. Bard, Inc.
Cardiovascular · 31d
Cleared Jan 12, 2015
Surefire Infusion System 021
K143588 · DQO
Surefire Medical, Inc.
Cardiovascular · 25d
Cleared Jan 09, 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · DQO
Cook, Inc.
Cardiovascular · 466d
Cleared Jan 09, 2015
SPINOUS PROCESS FUSION (SPF) PLATE
K140046 · PEK
Spinal Simplicity, LLC
Orthopedic · 366d
Cleared Jan 09, 2015
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D...
K141114 · MRG
Bio-Rad Laboratories
Chemistry · 254d
Cleared Jan 09, 2015
ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
K141132 · PEB
Biofilm, Inc.
Obstetrics & Gynecology · 253d
Cleared Jan 09, 2015
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
K141253 · MNI
New Era Orthopaedics, LLC
Orthopedic · 240d
Cleared Jan 09, 2015
PASS LP SPINAL SYSTEM
K141398 · NKB
Medicrea International SA
Orthopedic · 226d
Cleared Jan 09, 2015
MENNTOR X7
K141441 · DSI
Mennen Medical , Ltd.
Cardiovascular · 221d
Cleared Jan 09, 2015
CARDIOGARD EMBOLI PROTECTION CANNULA
K141465 · DWF
Cardiogard Medical, Ltd.
Cardiovascular · 220d
Cleared Jan 09, 2015
ILLUMINATED MEDIASTINOSCOPE
K141622 · EWY
Aegis Surgical, Ltd.
Ear, Nose, Throat · 206d
Cleared Jan 09, 2015
TDX SP2 POWER WHEECHAIR
K141783 · ITI
Invacare Corporation
Physical Medicine · 191d
Cleared Jan 09, 2015
FOX MOBILE
K142059 · CAF
Vectura GmbH
Anesthesiology · 164d
Cleared Jan 09, 2015
NUSTAT, NUSTAT XR
K142363 · QSY
Beeken Biomedical
General & Plastic Surgery · 137d
Cleared Jan 09, 2015
Puritan OptiTranz Liquid Stuart Collection and Transport System
K142366 · JSM
Puritan Medical Products, LLC
Microbiology · 137d
Cleared Jan 09, 2015
Revolution Full Face Mask
K142554 · BZD
Respironics, Inc.
Anesthesiology · 120d
Cleared Jan 09, 2015
Medline Silicone Foley Catheter
K142635 · EZL
Medline Industries, Inc.
Gastroenterology & Urology · 114d
Cleared Jan 09, 2015
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann...
K142890 · NHA
Straumann USA, LLC
Dental · 98d
Cleared Jan 09, 2015
Extension Sets
K142974 · FPA
Hospira, Inc.
General Hospital · 87d