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
155617–155640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1983
ARTERIAL MICRO COLLECTION KIT
K833312 · JKA
Current Technologies, Inc.
Chemistry · 77d
Cleared Dec 08, 1983
AMBERLITE CG50 RESIN, 100-200 MESH
K833320 · KEA
Biosan Laboratories, Inc.
Pathology · 73d
Cleared Dec 08, 1983
IN THE EAR HEARING AID OMNI 100
K833333 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 72d
Cleared Dec 08, 1983
VENTREZYME EIA CONTROLS-IMMUNOASSAY
K833423 · JJY
Ventrex Laboratories, Inc.
Immunology · 66d
Cleared Dec 08, 1983
BLOOD SAFETY MODULE BSM2
K833440 · KOC
Hospal Medical Corp.
Hematology · 64d
Cleared Dec 08, 1983
CAPIJECT SYS CAPILLARY BLOOD COLLECT
K833475 · JKA
Terumo Medical Corp.
Toxicology · 63d
Cleared Dec 08, 1983
CLIRANS MODEL TAF 15 HOLLOW FIBER
K833503 · KOC
Terumo Medical Corp.
Gastroenterology & Urology · 64d
Cleared Dec 08, 1983
TOXI CHEM SERUM ALCOHOL CONTROL
K833514 · DKC
Fisher Diagnostics
Toxicology · 58d
Cleared Dec 08, 1983
CT SCANNING ACCESSORIES
K833531 · JAA
Lds Hospital
Radiology · 64d
Cleared Dec 08, 1983
MODIFICATION OF EMIT AND AMIKACIN ASSAY
K833546 · LDN
Syva Co.
Toxicology · 55d
Cleared Dec 08, 1983
RTP-5100-5200-5300 & 5400
K833560 · JAD
Adac Laboratories
Radiology · 51d
Cleared Dec 08, 1983
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY
K833623 · KLR
Syva Co.
Toxicology · 55d
Cleared Dec 08, 1983
BRONCHITRAC DF DUAL RESP/CATHETER
K833633 · BSY
Ackrad Laboratories
Anesthesiology · 52d
Cleared Dec 08, 1983
RESCUE VALVE
K833748 · CBP
Respironics, Inc.
Anesthesiology · 43d
Cleared Dec 08, 1983
BEHIND-THE-EAR HEARING AIDS T-87 &
K833775 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 42d
Cleared Dec 08, 1983
OTICON, E26P
K833803 · ESD
Oticon Corp.
Ear, Nose, Throat · 37d
Cleared Dec 08, 1983
DUAL LUMEN SUBCLAVIAN CANNULA
K833848 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 34d
Cleared Dec 08, 1983
COAGULASE PLASMA, HORSE & RABBIT EDTA
K833858 · JTL
Otisville Biotech, Inc.
Microbiology · 31d
Cleared Dec 08, 1983
MUELLER HINTON AGAR
K833861 · JTZ
American Biomedical Corp.
Microbiology · 31d
Cleared Dec 08, 1983
BACTROL GRAM SLIDE
K833901 · JTO
Difco Laboratories, Inc.
Pathology · 24d
Cleared Dec 08, 1983
BRETHANCER, DRUG DELIVERY SYS-INHAL
K833922 · CAF
Ciba-Geigy Corp.
Anesthesiology · 24d
Cleared Dec 08, 1983
CATALOG 6400 OXYGEN CONCENTRATOR
K833938 · CAW
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 23d
Cleared Dec 06, 1983
DIF-STET
K832882 · DQD
Intersect Systems, Inc.
Cardiovascular · 102d
Cleared Dec 06, 1983
MINI-PECG
K832883 · DPS
Intersect Systems, Inc.
Cardiovascular · 102d