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
140953–140976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1987
PERSONAL INFUSION PUMP
K864276 · FRN
Bionica, Inc.
General Hospital · 139d
Cleared Mar 17, 1987
DELTATRAC(TM) METABOLIC MONITOR
K864603 · BZL
Datex Division Instrumentarium Corp.
Anesthesiology · 113d
Cleared Mar 17, 1987
ALLERG*ENS ENZYME IMMUNOASSAY KIT
K864696 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 106d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 102d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K864848 · JTN
Organon Teknika Corp.
Microbiology · 97d
Cleared Mar 17, 1987
UNI-PULS(TENS) MODEL #292
K865063 · GZJ
Oms Medico, Inc.
Neurology · 83d
Cleared Mar 17, 1987
ACCUPEN(R)
K870078 · FMF
Ulster Scientific, Inc.
General Hospital · 68d
Cleared Mar 17, 1987
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
K870089 · GTJ
Microscan Div. Baxter Healthcare Corp.
Microbiology · 67d
Cleared Mar 17, 1987
MODIFIED JIMMY JOHN III
K870127 · KPL
Colon Therapeutics
Gastroenterology & Urology · 67d
Cleared Mar 17, 1987
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
K870233 · GKZ
Abbott Diagnostics
Hematology · 55d
Cleared Mar 17, 1987
DACOMED PENILE PROSTHESIS SIZER
K870320 · JLW
Dacomed Corp.
Chemistry · 48d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSITIVITY DISKS
K870348 · JTN
Difco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 17, 1987
JIMMY JOHN III, COLONIC IRRIGATION SYSTEM
K870376 · KPL
Colon Therapeutics
Gastroenterology & Urology · 47d
Cleared Mar 17, 1987
MYA-1 AND MYT-1 MYELOGRAM TRAY
K870418
North Coast Medi-Tek
Cardiovascular · 42d
Cleared Mar 17, 1987
SS-DNA EIA DIAGNOSTIC KIT
K870452 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
SM EIA DIAGNOSTIC KIT
K870455 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
DNP EIA DIAGNOSTIC KIT
K870456 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
RNP EIA DIAGNOSTIC KIT
K870457 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
HISTONES EIA DIAGNOSTIC KIT
K870458 · DHN
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
NEU-PULS(TENS) MODEL #295
K870583 · GZJ
Oms Medico, Inc.
Neurology · 34d
Cleared Mar 17, 1987
AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE
K870720 · CBT
American Pharmaseal Div. Ahsc
Anesthesiology · 25d
Cleared Mar 17, 1987
KEELER PULSAIR NON CONTACT TONOMETER
K870750 · HKX
Keeler Instruments, Inc.
Ophthalmic · 20d
Cleared Mar 17, 1987
THE (CROM) TESTER
K870767 · KQW
Twin City Surgical, Inc.
Neurology · 19d
Cleared Mar 17, 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
K870870 · JTN
Organon Teknika Corp.
Microbiology · 14d