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
138145–138168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1987
PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT
K873545 · EHZ
Commercial Products & Engineering Co.
Dental · 80d
Cleared Nov 20, 1987
GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES
K873564 · LKT
Genetic Systems Corp.
Microbiology · 79d
Cleared Nov 20, 1987
ACRYLIC BASE DENTURE MATERIALS
K873738 · EBI
E&D Dental Manufacturing Co.
Dental · 66d
Cleared Nov 20, 1987
EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001
K873809 · BWA
Zimmer Aspen Labs
General & Plastic Surgery · 63d
Cleared Nov 20, 1987
THE EXTRACTOR(TM)
K873932 · DKO
Molecular Biosystems, Inc.
Microbiology · 56d
Cleared Nov 20, 1987
NICOLET DISPOSABLE PRASS PROBE
K873964 · ETN
Nicolet Biomedical Instruments
Ear, Nose, Throat · 52d
Cleared Nov 20, 1987
LAKE WOUND CARE/TREATMENT KIT
K873973 · LRO
Lake Medical Products, Inc.
General & Plastic Surgery · 52d
Cleared Nov 20, 1987
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
K874256 · JTN
Organon Teknika Corp.
Microbiology · 31d
Cleared Nov 20, 1987
REVISED LABELING FOR CANNABINOIDS TEST KIT
K874269 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 31d
Cleared Nov 20, 1987
PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL
K874304 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 31d
Cleared Nov 20, 1987
MODEL A-70, BEHIND-THE-EAR HEARING AID
K874323 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 30d
Cleared Nov 20, 1987
TX-2(TENS)
K874333 · GZJ
Oms Medico, Inc.
Neurology · 29d
Cleared Nov 20, 1987
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 23d
Cleared Nov 20, 1987
SOFT TISSUE ANCHORING SET KIT
K874439 · LRO
Concept, Inc.
General & Plastic Surgery · 23d
Cleared Nov 20, 1987
SPERMICIDAL CONDOM
K874464 · HIS
Royal American Industries, Inc.
Obstetrics & Gynecology · 25d
Cleared Nov 20, 1987
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
K874537 · JSE
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 20, 1987
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516
K874538 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 20, 1987
TX-4(TENS) (SIGMA TENS)
K874550 · GZJ
Oms Medico, Inc.
Neurology · 16d
Cleared Nov 20, 1987
DYNATECH MR 250 MANUAL MICROELISA READER
K874598 · JTC
Dynatech Laboratories, Inc.
Microbiology · 11d
Cleared Nov 18, 1987
KTP/532 LASER
K873330 · LNK
Laserscope
Gastroenterology & Urology · 91d
Cleared Nov 17, 1987
DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF
K872006 · FGD
Mac Lee Medical Products
Gastroenterology & Urology · 175d
Cleared Nov 17, 1987
RICH-MAR CONDUCTIVE GEL
K872036 · IPF
Rich-Mar Corp.
Physical Medicine · 174d
Cleared Nov 17, 1987
BLOOD CONTAINMENT PACK
K872448 · LRO
Professional Medical Services
General & Plastic Surgery · 147d
Cleared Nov 17, 1987
SURFACE TEMPERATURE SCANNER
K873010 · FLL
Omega Medical Corp.
General Hospital · 105d