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
140617–140640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1987
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
K870948 · DTB
Intermedics, Inc.
Cardiovascular · 32d
Cleared Apr 10, 1987
LCA 2000
K871034 · FTA
Vistek Corp.
General & Plastic Surgery · 24d
Cleared Apr 10, 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Apr 10, 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Apr 10, 1987
OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
K871074 · FWP
Omega Silicone, Inc.
General & Plastic Surgery · 23d
Cleared Apr 10, 1987
ANADIAS ZARA SYSTEM MALAR IMPLANTS
K871190 · FWP
Anadias, Inc.
General & Plastic Surgery · 17d
Cleared Apr 10, 1987
KOTEX PROFILE SHAPED MAXI PAD
K871210 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 16d
Cleared Apr 10, 1987
KADIR HI-TORQUE GUIDE WIRE
K871297 · KOD
Argon Medical Corp.
Gastroenterology & Urology · 10d
Cleared Apr 09, 1987
MEDI-TECH SELECTIVE TORQUE CATHETER
K864118 · DQY
Medi-Tech, Inc.
Cardiovascular · 170d
Cleared Apr 09, 1987
Q5000 STRESS TEST MONITOR
K864504 · DPS
Quinton, Inc.
Cardiovascular · 146d
Cleared Apr 09, 1987
MODEL LS 860, CO2 LASER
K864562 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 141d
Cleared Apr 09, 1987
MODEL LS 840, CO2 LASER
K864563 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 141d
Cleared Apr 09, 1987
ACKRAD TDI SET
K864818 · KRB
Ackrad Laboratories
Cardiovascular · 121d
Cleared Apr 09, 1987
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
K870675 · DQY
Quinton, Inc.
Cardiovascular · 49d
Cleared Apr 09, 1987
TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER
K870729 · DTK
Medi-Tech, Inc.
Cardiovascular · 43d
Cleared Apr 09, 1987
EK10 ELECTROCARDIOGRAPH
K870880 · DPS
Burdick Corp.
Cardiovascular · 36d
Cleared Apr 09, 1987
INTRODUCER, PERCUTANEOUS
K870907 · DYB
Med Fusion Systems, Inc.
Cardiovascular · 35d
Cleared Apr 08, 1987
SZAC-16 SEIZURE ANALYSIS COMPUTER
K870450 · OMB
Grass-Telefactor Product Group
Neurology · 64d
Cleared Apr 08, 1987
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521 · JHI
Hybritech, Inc.
Chemistry · 61d
Cleared Apr 08, 1987
MLC NORMAL SERUM
K870580 · KIS
Rjo Biologicals, Inc.
Pathology · 56d
Cleared Apr 08, 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963 · LIO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 29d
Cleared Apr 08, 1987
CM 5000 MONITOR AIRWAY PRESSURE
K871083 · CAP
Canadian Monaghan , Ltd.
Anesthesiology · 21d
Cleared Apr 08, 1987
MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT
K871278 · LJP
California Integrated Diagnostics, Inc.
Microbiology · 8d
Cleared Apr 08, 1987
MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT
K871279 · JWZ
California Integrated Diagnostics, Inc.
Microbiology · 8d