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
142153–142176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1986
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 28, 1986
MICRO-READER
K864060 · JJQ
Hyperion, Inc.
Chemistry · 39d
Cleared Nov 28, 1986
OPHTHALMIC SURGICAL INSTRUMENTS
K864183 · HNR
Techno Ophthalmics Intl.
Ophthalmic · 32d
Cleared Nov 28, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K864230 · CKE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 31d
Cleared Nov 28, 1986
OPHTHALMIC KNIFE & FORCEPS
K864266 · HNR
Western Medical Products, Inc.
Ophthalmic · 30d
Cleared Nov 28, 1986
BL1 (HARD CONTACT LENS)
K864343 · HPX
Beta Labs, Inc.
Ophthalmic · 24d
Cleared Nov 28, 1986
LANDERS INDIRECT VITRECTOMY LENS
K864418 · HJK
Ocular Instruments, Inc.
Ophthalmic · 18d
Cleared Nov 28, 1986
THERMOSTABLE NUCLEASE TEST AGAR
K864454 · JSH
Dimed, Intl.
Microbiology · 16d
Cleared Nov 26, 1986
PLOTTER MODEL (MP100)
K861905
Madsen Electronics (Canada) , Ltd.
Gastroenterology & Urology · 194d
Cleared Nov 26, 1986
TELERADIOGRAPHY SYSTEM
K862744 · LMD
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 128d
Cleared Nov 26, 1986
ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+
K863176 · LYC
Coors Biomedical Co.
Dental · 100d
Cleared Nov 26, 1986
VELCOM-100
K863210 · DPW
Waters Instruments, Inc.
Cardiovascular · 98d
Cleared Nov 26, 1986
CARDS(TM) STREP A CATALOG NO. CR-7545
K863647 · GTZ
Pacific Biotech, Inc.
Microbiology · 69d
Cleared Nov 26, 1986
OMNI-FIL
K863876 · EBF
Inpromas
Dental · 51d
Cleared Nov 26, 1986
SPAND-GEL GRANULATED GEL
K864124 · KMF
Medi-Tech Intl. Corp.
General & Plastic Surgery · 36d
Cleared Nov 26, 1986
MICROSELECTRON-HDR (HIGH DOSE RATE)
K864210 · JAQ
Nucletron-Oldelft Corp.
Radiology · 29d
Cleared Nov 26, 1986
VERINOR ALLOY
K864306 · EJT
Degussa Dental, Inc.
Dental · 23d
Cleared Nov 26, 1986
STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)
K864311 · FYA
Clinitech, Inc.
General Hospital · 23d
Cleared Nov 26, 1986
RAYLOR(TM) PERIOSTEAL ELEVATORS
K864421 · GEG
Cedar Surgical, Inc.
General & Plastic Surgery · 16d
Cleared Nov 26, 1986
RAYLOR(TM) PROTECTIVE RETRACTOR
K864424 · GAD
Cedar Surgical, Inc.
General & Plastic Surgery · 16d
Cleared Nov 26, 1986
RAYLOR(TM) DEPTH GAUGE
K864426 · HTJ
Cedar Surgical, Inc.
Orthopedic · 16d
Cleared Nov 26, 1986
DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
K864474 · EHD
Planmeca USA, Inc.
Radiology · 13d
Cleared Nov 25, 1986
MEDA 2500 T.E.N.S.
K862450 · GZJ
Watlow/Winona, Inc.
Neurology · 151d
Cleared Nov 25, 1986
MUSCLE MASTER (BIPOLAR STIMULATOR)
K862685 · IPF
Modern Systems Technology, Inc.
Physical Medicine · 133d