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
141025–141048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1987
HEARING AID TEST SYSTEM MODEL HAT 1000
K870229 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 51d
Cleared Mar 13, 1987
INTERMATE(TM)
K870242 · FRN
Infusion Systems Corp.
General Hospital · 51d
Cleared Mar 13, 1987
#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
K870324 · FMG
Clinical Connections, Inc.
General Hospital · 44d
Cleared Mar 13, 1987
EZ COMPLEMENT REAGENTS, 78N2212
K870351 · DHL
Diamedix Corp.
Immunology · 43d
Cleared Mar 13, 1987
INSTAJECT
K870474 · KZH
Pavel Jordan & Associates, Inc.
General Hospital · 38d
Cleared Mar 13, 1987
DEPEND UNDERPAD
K870522 · KME
Kimberly-Clark Corp.
General Hospital · 35d
Cleared Mar 13, 1987
FAST GLUCOSE
K870631 · CGA
Sclavo, Inc.
Chemistry · 28d
Cleared Mar 13, 1987
FAST URIC ACID
K870632 · KNK
Sclavo, Inc.
Chemistry · 28d
Cleared Mar 13, 1987
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
K870691 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 13, 1987
AC ADAPTER ACCESSORY, PRODUCT CODE 600123A
K870768 · FRN
Deltec Systems, Inc.
General Hospital · 15d
Cleared Mar 13, 1987
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT
K870776 · CEO
Reagents Applications, Inc.
Chemistry · 15d
Cleared Mar 13, 1987
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER
K870777 · JJF
Kone Instruments, Inc.
Chemistry · 15d
Cleared Mar 13, 1987
EMG ELECTRODES AND EXTENSION CORDS
K870795 · IKT
Nihon Kohden America, Inc.
Neurology · 15d
Cleared Mar 13, 1987
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
K870827 · CDT
Intersect Systems, Inc.
Chemistry · 10d
Cleared Mar 13, 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828 · CHH
Intersect Systems, Inc.
Chemistry · 10d
Cleared Mar 13, 1987
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
K870844 · HWB
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
SCHULTZ MP COMPONENT PUNCH
K870846 · HWP
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
SCHULTZ PHALANGEAL COMPONENT DRIVER
K870847 · HWR
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
SCHULTZ METACARPAL COMPONENT DRIVER
K870848 · HWR
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER
K870964 · IYO
Elscint, Inc.
Radiology · 3d
Cleared Mar 12, 1987
BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K863877 · JXM
General Diagnostics
Toxicology · 157d
Cleared Mar 12, 1987
RICKETTSIAL IGG AND IGM IFA KIT
K864110 · GPN
Hillcrest Biologicals
Microbiology · 142d
Cleared Mar 12, 1987
APO B., IMMUNOTURBIDIMETRIC ASSAY
K864228 · MSJ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 135d
Cleared Mar 12, 1987
BECKMAN EPSILON(TM) LIPASE TEST KIT
K864438 · CET
Beckman Instruments, Inc.
Chemistry · 120d