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
148585–148608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1985
MFE CARDIAC STRESS SYSTEM
K850868
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
MFE COUCH ERGOMETER
K850869 · ISD
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
MEDIFETTE ERGOMETER
K850870
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL
K850873 · INO
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR
K850877 · ILK
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
AGGRO/LINK COMPUTER INTERFACE
K851025 · JBX
Chrono-Log Corp.
Hematology · 93d
Cleared Jun 12, 1985
COBE SYSTEM 3
K851306 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 12, 1985
STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
K851362 · FKH
Rna Medical Corp.
Gastroenterology & Urology · 69d
Cleared Jun 12, 1985
HEMODIALYSIS CONCENTRATE ADDITIVES
K851431 · KPO
Dana Laboratories
Gastroenterology & Urology · 63d
Cleared Jun 12, 1985
VALTRAC PURSESTING DEVICE
K851452 · HCF
Davis & Geck, Inc.
General & Plastic Surgery · 62d
Cleared Jun 12, 1985
BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR
K851470 · KNX
Lic-Orthion
Gastroenterology & Urology · 58d
Cleared Jun 12, 1985
TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR
K851471 · KNX
Lic-Orthion
Gastroenterology & Urology · 58d
Cleared Jun 12, 1985
CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO
K851539 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 57d
Cleared Jun 12, 1985
PREFER INCONTINENCE AID
K851876 · EYQ
Rocky Mountain Medical Corp.
Gastroenterology & Urology · 44d
Cleared Jun 12, 1985
SURGICAL STARTER KIT
K852112
Devon Industries, Inc.
General & Plastic Surgery · 28d
Cleared Jun 12, 1985
BSM 22 BLOOD SAFETY MODULE
K852134 · KOC
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Jun 12, 1985
BSM 21 BLOOD SAFETY MODULE
K852135 · KOC
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Jun 12, 1985
MNI 400 INJECTION CAPS
K852162 · LFJ
Med-West, Inc.
Gastroenterology & Urology · 23d
Cleared Jun 12, 1985
JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT
K852297 · EXB
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 14d
Cleared Jun 11, 1985
DOSIMETRIC RELEASE OF RAD. TUBING PAC
K833047 · DWF
American Bentley
Cardiovascular · 644d
Cleared Jun 11, 1985
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · DRS
Hewlett-Packard Co.
Cardiovascular · 295d
Cleared Jun 11, 1985
CORDIS ELECTROPHYSIOLOGY STIMULATOR
K844815 · JOQ
Cordis Corp.
Cardiovascular · 182d
Cleared Jun 11, 1985
MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
K844834 · EOQ
Machida America, Inc.
Ear, Nose, Throat · 181d
Cleared Jun 11, 1985
RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
K851284 · CZP
Cooper Biomedical, Inc.
Immunology · 71d