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
150433–150456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR LEAD
K842145 · DTD
Medtronic Vascular
Cardiovascular · 233d
Cleared Jan 18, 1985
PATIENT MONITOR 78354A
K842236 · DRT
Hewlett-Packard Co.
Cardiovascular · 227d
Cleared Jan 18, 1985
MODEL 503FB
K842759 · LOS
Atrix
Cardiovascular · 186d
Cleared Jan 18, 1985
ESKA MULTISTAGE ESOPHAGEAL BOUGIE
K843186 · FAT
Dacomed Corp.
Gastroenterology & Urology · 158d
Cleared Jan 18, 1985
MODULAR FIBERSCOPE SYSTEM
K843683 · GCP
Reichert Scientific Instruments
Gastroenterology & Urology · 122d
Cleared Jan 18, 1985
STERILE SALINE SOLUTION
K843797 · BSY
Paco Pharmaceutical Services, Inc.
Anesthesiology · 113d
Cleared Jan 18, 1985
SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
K844051 · NXA
Washington-Greene County Branch...
Anesthesiology · 93d
Cleared Jan 18, 1985
FORCEPS & HAMOSTATS
K844062 · GEN
I M, Inc.
General & Plastic Surgery · 92d
Cleared Jan 18, 1985
COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH
K844066 · CGJ
Clinetics Corp.
Chemistry · 92d
Cleared Jan 18, 1985
CARDIOPAC DEFIBRILLATOR 444
K844103 · LDD
Birtcher Corp.
Cardiovascular · 87d
Cleared Jan 18, 1985
LP-5
K844179 · CBK
Life Products, Inc.
Anesthesiology · 84d
Cleared Jan 18, 1985
GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR
K844216 · JXE
Grass Instrument Co.
Neurology · 79d
Cleared Jan 18, 1985
UNITED SKIN BARRIER PASTE
K844341 · EZR
Howmedica Corp.
Gastroenterology & Urology · 71d
Cleared Jan 18, 1985
SARTORIUS MINISART SM 16596HY
K844504 · KOC
Sartorius Filters, Inc.
Gastroenterology & Urology · 59d
Cleared Jan 18, 1985
TDX TOTAL ESTRIOL
K844511 · CGI
Abbott Laboratories
Chemistry · 59d
Cleared Jan 18, 1985
MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI
K844559 · JGS
Thermo Orion
Chemistry · 58d
Cleared Jan 18, 1985
PRE-KLENE ENAMEL CLEANER
K844572 · EFT
Medical Products Laboratories, Inc.
Dental · 56d
Cleared Jan 18, 1985
AVL MODEL 982 ELECTROLYTE ANALYZER
K844587 · JGS
Avl Scientific Corp.
Chemistry · 56d
Cleared Jan 18, 1985
ASAHI NEW PAN-SERIES HEMOFILTERS
K844663 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 49d
Cleared Jan 18, 1985
PEDIATRIC SIZED HEMOCATH CATHETER
K844692 · FIQ
Quinton, Inc.
Gastroenterology & Urology · 46d
Cleared Jan 18, 1985
SURGICAL SCALPEL BLADES & DISPOSABLES
K844759 · GES
Cross Country Paper Products Corp.
General & Plastic Surgery · 42d
Cleared Jan 18, 1985
NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR
K844786 · FYC
Durawear
General Hospital · 39d
Cleared Jan 18, 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · JQP
Miles Laboratories, Inc.
Chemistry · 32d
Cleared Jan 18, 1985
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 31d