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
141193–141216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1987
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
K870323 · DTE
Pace Medical
Cardiovascular · 34d
Cleared Mar 03, 1987
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
K870394 · FIB
Clinical Connections, Inc.
Gastroenterology & Urology · 32d
Cleared Mar 03, 1987
DAIG PACEMAKER LEAD ADAPTOR
K870562 · DTD
Daig Corp.
Cardiovascular · 21d
Cleared Mar 03, 1987
VEIN GRAFT EAR SCISSORS
K870756 · JZB
Treace Medical, Inc.
Ear, Nose, Throat · 5d
Cleared Mar 03, 1987
EAR LOOP
K870761 · JYQ
Treace Medical, Inc.
Ear, Nose, Throat · 5d
Cleared Mar 02, 1987
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
K863221 · HHR
Laserscope
Obstetrics & Gynecology · 193d
Cleared Mar 02, 1987
THERMAPAD
K864158 · KME
Avail-Southwest Division
General Hospital · 130d
Cleared Mar 02, 1987
S.C.T. MULTI PORT, INJECTION SITE
K864296 · FPA
Salt Creek Medical Technologies
General Hospital · 122d
Cleared Mar 02, 1987
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K870331 · EGG
Interpore Intl.
Dental · 33d
Cleared Mar 02, 1987
INTRAUTERINE INSEMINATION CATHETER
K870551 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 20d
Cleared Mar 02, 1987
ALPHA-DENT PIT AND FISSURE SEALANT
K870579 · EBC
Wallace A. Erickson & Co.
Dental · 20d
Cleared Feb 27, 1987
THE INJECTOR
K862325 · KZH
American Medical Innovations, Inc.
General Hospital · 253d
Cleared Feb 27, 1987
KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM
K862686 · ITX
Kontron Instruments, Inc.
Radiology · 227d
Cleared Feb 27, 1987
PROFESSIONAL DISINFECTION SYSTEM (PDS)
K863346 · LPN
Ciba Vision Care
Ophthalmic · 182d
Cleared Feb 27, 1987
DIAGNOSTIC ULTRASONIC TRANSDUCER
K863364 · ITX
Toshiba Medical Systems
Radiology · 178d
Cleared Feb 27, 1987
POREX(TM) EYE SPHERE IMPLANT
K863943 · HPZ
Porex Medical
Ophthalmic · 140d
Cleared Feb 27, 1987
POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
K863946 · HQX
Porex Medical
Ophthalmic · 140d
Cleared Feb 27, 1987
SOLUSET CALCIUM DEMINERALIZING SOLUTION
K864976 · EKS
Endo Technic Corp.
Dental · 70d
Cleared Feb 27, 1987
MEDTRAC VP VOLUMETRIC INFUSION PUMP
K864997 · FRN
American Edwards Laboratories
General Hospital · 67d
Cleared Feb 27, 1987
INFUMIX MIXING CONTAINER
K870052 · KPE
Biodynamics Corp.
General Hospital · 51d
Cleared Feb 27, 1987
A+MED DISPOSABLE NEEDLE
K870193 · FMI
Can-Am Surgical Corp.
General Hospital · 38d
Cleared Feb 27, 1987
COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM
K870266 · EBF
Coltene, Inc.
Dental · 35d
Cleared Feb 27, 1987
STRYKER MODEL 977 BIRTHING BED
K870745 · KNC
Stryker Corp.
Obstetrics & Gynecology · 2d
Cleared Feb 26, 1987
FUJI CR IMAGING PLATE
K862414 · EAM
Parexel Intl. Corp.
Radiology · 246d