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
147889–147912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1985
SITE INFUSION CONTACT LENS W/ILLUMINATOR
K852187
Microsurgical Systems, Inc.
Ophthalmic · 72d
Cleared Jul 31, 1985
DENTAL CASTING ALLOY GDC 1686
K852347 · EJS
Deringer-Ney, Inc.
Dental · 61d
Cleared Jul 31, 1985
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 56d
Cleared Jul 31, 1985
INTERPLAK
K852476 · JEQ
Dental Research Corp.
Dental · 50d
Cleared Jul 31, 1985
SATLEC PROPHY UNIT PU 3055
K852521 · KOJ
Spelna, Inc.
Dental · 47d
Cleared Jul 31, 1985
SATALEC SERVOTORQUE S2 SX2
K852524 · EIA
Spelna, Inc.
Dental · 47d
Cleared Jul 31, 1985
ATL 225 MW TRAIL LENS SET
K852548 · HPA
Ascon Medical Instruments, Ltd.
Ophthalmic · 49d
Cleared Jul 31, 1985
A-COMPANY ELASTIC LIGATURE RINGS
K852596 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ELASTIC ROTATION WEDGES
K852597 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY SEPARATING ELASTICS
K852598 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ELASTOMERIC TUBING
K852599 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ELASTOMERIC CHAIN DISPENSER
K852600 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ESPREE SAFETY HEADGEAR
K852670 · DZB
A Company, Inc.
Dental · 37d
Cleared Jul 31, 1985
HEARING AID, UNITRON MODEL UM60-H
K852690 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 36d
Cleared Jul 31, 1985
PORCELAIN VENEER SYSTEM LABORATORY KIT
K852743 · EIH
The S. S. White Co.
Dental · 34d
Cleared Jul 31, 1985
TELEDYNE GETZ BARRIER-DENTIN SEALER
K852756 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 33d
Cleared Jul 31, 1985
A-COMPANY SELF-LIGATING APPLIANCE
K852800 · EJF
A Company, Inc.
Dental · 30d
Cleared Jul 31, 1985
GLOSSY POLISHING PASTE
K852814 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 29d
Cleared Jul 31, 1985
DURACLEAN DENTURE CLEANER
K852906 · JER
Astron Dental Corp.
Dental · 22d
Cleared Jul 31, 1985
OHMEDA 5120 OXYGEN MONITOR
K853082 · CCL
Ohmeda Medical
Anesthesiology · 8d
Cleared Jul 30, 1985
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K844818 · KWL
Osteonics Corp.
Orthopedic · 231d
Cleared Jul 30, 1985
ELECTRODE FOR NEUROLOGICAL SURGERY 2111
K845035 · GYC
Progress Mankind Technology
Neurology · 215d
Cleared Jul 30, 1985
WYLER SUBDURAL STRIP ELECTRODE
K850342 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 183d
Cleared Jul 30, 1985
HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
K851566 · JDG
Howmedica Corp.
Orthopedic · 105d