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
142033–142056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1986
CANCELLOUS BONE SCREW
K864626 · HWC
Dow Corning Wright
Orthopedic · 20d
Cleared Dec 12, 1986
CREATINKINETIC
K863079 · CGX
J. D. Assoc.
Chemistry · 122d
Cleared Dec 12, 1986
SYPH-TRUST
K863368 · GMQ
I.A.F. Production, Inc.
Microbiology · 100d
Cleared Dec 12, 1986
EUB-400 DIAGNOSTIC ULTRASOUND DEVICE
K863576 · IYO
Hitachi Medical Corp. of America
Radiology · 91d
Cleared Dec 12, 1986
MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS
K863667 · JWH
Depuy, Inc.
Orthopedic · 85d
Cleared Dec 12, 1986
MAINSTER RETINA LASER LENS
K863911 · HJK
Ocular Instruments, Inc.
Ophthalmic · 65d
Cleared Dec 12, 1986
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · FRN
Abbott Laboratories
General Hospital · 59d
Cleared Dec 12, 1986
IRAS PERIMETER
K864012 · HPJ
Randwal Instrument Co., Inc.
Ophthalmic · 58d
Cleared Dec 12, 1986
STERILABELS
K864015 · LDQ
Diversatronics, Inc.
General & Plastic Surgery · 58d
Cleared Dec 12, 1986
RAYLOR(TM) DISSECTING HOOK
K864425 · GDG
Cedar Surgical, Inc.
General & Plastic Surgery · 32d
Cleared Dec 12, 1986
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K864517 · FRN
Medtronic Minimed
General Hospital · 25d
Cleared Dec 11, 1986
INTRAUTERINE CATHETER
K861305 · HDR
Ram Development
Obstetrics & Gynecology · 248d
Cleared Dec 11, 1986
DYMAX PERSONAL SCANNER
K862127 · IYO
Dymax Corp
Radiology · 190d
Cleared Dec 11, 1986
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · FOZ
Arrow Intl., Inc.
General Hospital · 189d
Cleared Dec 11, 1986
MAKLER CATHETER
K863785 · HDR
I M, Inc.
Obstetrics & Gynecology · 76d
Cleared Dec 11, 1986
MODIFIED SARNS MEMBRANE OXYGENATOR
K863902 · DTX
3M Health Care, Sarns
Cardiovascular · 65d
Cleared Dec 11, 1986
STOCKERT-SHILEY CAPS BATTERY MODULE
K863960 · DTQ
Shiley, Inc.
Cardiovascular · 62d
Cleared Dec 11, 1986
BBL CAMPYSLIDE(TM) TEST
K864027 · LQP
Bd Becton Dickinson Vacutainer...
Microbiology · 57d
Cleared Dec 11, 1986
BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR
K864179 · FKT
Ash Medical Systems, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 11, 1986
KOTEX (R) GOODNITES
K864187 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 45d
Cleared Dec 11, 1986
NORFLOXACIN SUSCEPTIBILITY POWDER
K864442 · JTT
Merck, Sharp & Dohme
Microbiology · 29d
Cleared Dec 11, 1986
MODIFIED VSM 2 VITAL SIGNS MONITOR
K864665 · DXN
Physio-Control Corp.
Cardiovascular · 10d
Cleared Dec 11, 1986
MODIFIED LIFESTAT 200
K864666 · DXN
Physio-Control Corp.
Cardiovascular · 10d
Cleared Dec 10, 1986
ALT S.C.E. (GPT)
K863053 · CKA
J. D. Assoc.
Chemistry · 120d