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
137833–137856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1987
CALIBRATION GAS FOR CARBON DIOXIDE MONITOR
K874297 · BXK
Liquid Air Corp.
Anesthesiology · 62d
Cleared Dec 21, 1987
RESPIRGARD II NEBULIZER SYSTEM
K874395 · CAF
Marquest Medical Products, Inc.
Anesthesiology · 54d
Cleared Dec 21, 1987
BABYFLEX PATIENT CIRCUIT
K874559 · BZO
Airoflex Medical, Inc.
Anesthesiology · 47d
Cleared Dec 21, 1987
SEALFLEX MASK
K874746 · BSJ
Engineered Medical Systems
Anesthesiology · 33d
Cleared Dec 18, 1987
MEC-I-TRON, MODEL P-1
K873190 · GZJ
Meyer Equipment Company, Inc.
Neurology · 127d
Cleared Dec 18, 1987
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K873771 · GYK
American V. Mueller
Neurology · 93d
Cleared Dec 18, 1987
NDNA ANTIBODY TEST KIT
K874191 · LRM
Lipogen, Inc.
Immunology · 65d
Cleared Dec 18, 1987
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281 · DHB
Medix Biotech, Inc.
Immunology · 59d
Cleared Dec 18, 1987
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
K874339 · DSK
A&D Engineering, Inc.
Cardiovascular · 58d
Cleared Dec 18, 1987
PCI MODEL RS100 TELEMETRY MONITOR
K874387 · DXH
Accucore, Inc.
Cardiovascular · 53d
Cleared Dec 18, 1987
MWI 400 WOUND DRESSING
K874470 · NAD
Med-West, Inc.
General & Plastic Surgery · 46d
Cleared Dec 18, 1987
IMACK-MB TEST PROCEDURE (MODIFICATION)
K874545 · JHY
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Dec 18, 1987
KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED
K874547 · JWH
Kirschner Medical Corp.
Orthopedic · 45d
Cleared Dec 18, 1987
ENVISAN PASTE
K874553 · KOZ
Marion Laboratories, Inc.
General & Plastic Surgery · 44d
Cleared Dec 18, 1987
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
K874603 · KLI
Ciba Corning Diagnostics Corp.
Chemistry · 39d
Cleared Dec 18, 1987
FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301
K874622 · JLW
Cyberfluor, Inc.
Chemistry · 38d
Cleared Dec 18, 1987
TDXR DELTA-9-CANNABINOIDS
K874646 · LDJ
Abbott Laboratories
Chemistry · 35d
Cleared Dec 18, 1987
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
K874658 · CEE
Technicon Instruments Corp.
Chemistry · 36d
Cleared Dec 18, 1987
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
K874703 · LCD
Syva Co.
Toxicology · 32d
Cleared Dec 18, 1987
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Dec 18, 1987
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
K874740 · JDG
Dow Corning Wright
Orthopedic · 30d
Cleared Dec 18, 1987
FUKUDA DENSHI MODEL FCP-231
K874768 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 29d
Cleared Dec 18, 1987
MULTICHEM CHLORIDE REAGENT S0933
K874812 · CHJ
Simmler, Inc.
Chemistry · 24d
Cleared Dec 18, 1987
MAGNESIUM
K874847 · JGJ
Tech-Co, Inc.
Chemistry · 24d