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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156025–156048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1983
INTREX
K833241 · EAP
Pennwalt Corp.
Radiology · 67d
Cleared Oct 28, 1983
MAMMOGRAPHIC S-RAY SYSTEM
K833243 · IZH
Xerox Medical Systems
Radiology · 71d
Cleared Oct 28, 1983
STREPTOCOCCUS ID TRIPLATE SYSTEM
K833254 · JSI
Granite Diagnostics, Inc.
Microbiology · 38d
Cleared Oct 28, 1983
STAIN PACK FOR AEROSPRAY SLIDE STAINER
K833260 · IAF
Wescor, Inc.
Hematology · 35d
Cleared Oct 28, 1983
RESPIR GARD-II OXYGARD HYDROGARD-SPIRO
K833267 · CAH
Marquest Medical Products, Inc.
General Hospital · 37d
Cleared Oct 28, 1983
SABOURAUD DEXTROSE AGAR, EMMONS
K833296 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 36d
Cleared Oct 28, 1983
FEELEY-GORMAN AGAR
K833301 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 36d
Cleared Oct 27, 1983
GUTTMAN INFUSION NEEDLE
K830568 · FMI
Cosmetic Sciences, Inc.
General Hospital · 247d
Cleared Oct 27, 1983
WLECTROCARDIOGRAPH ECG-7204
K831274 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 191d
Cleared Oct 27, 1983
CMV IGM TEST
K831711 · LKQ
Gull Laboratories, Inc.
Immunology · 153d
Cleared Oct 27, 1983
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
K831825 · KPJ
Hospitak, Inc.
General & Plastic Surgery · 142d
Cleared Oct 27, 1983
PACEMAKER PROGRAMMER #2032
K831859 · DXY
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
GENERATOR, PULSE, PACEMAKER #532
K831860 · DXY
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
SHARE INT'L TDM
K832067 · HCJ
Share Int'L
Neurology · 122d
Cleared Oct 27, 1983
COAT-A-COUNT FREE T3 RIA KIT
K832164 · CDP
Diagnostic Products Corp.
Chemistry · 114d
Cleared Oct 27, 1983
YBBOTT CMV TOTAL AB EIA
K832221 · LFZ
Abbott Laboratories
Microbiology · 111d
Cleared Oct 27, 1983
SLIMB SINGLE LIMB BREATHING CIRCUIT
K832453 · CAI
Respiratory Care, Inc.
Anesthesiology · 93d
Cleared Oct 27, 1983
CS-11
K832500 · EBE
Chema-Scutum, Inc.
Dental · 92d
Cleared Oct 27, 1983
SOLUTION ADMIN. LINE W/SPIKE
K832549 · FPA
Vascular Specialties, Inc.
General Hospital · 87d
Cleared Oct 27, 1983
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
K832809 · JQW
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Oct 27, 1983
ACA TOBRAMYCIN CALIBRATOR
K832982 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Oct 27, 1983
TOBRAMYCIN ANALYTICAL TEST PACK-ACA
K832985 · KLB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Oct 27, 1983
CIN AGAR YERSINIA-SELECTIVE AGAR
K833010 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 51d
Cleared Oct 27, 1983
HCC-MYCOBACTERIA STAIN KIT
K833131 · LIB
Dr. C.V. Jacob
Microbiology · 44d