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
169489–169512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1979
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)
K791476 · JSF
Isle Media and Sterile Products, Inc.
Microbiology · 39d
Cleared Sep 04, 1979
XLD AGAR (XYLASE LYSINE DESOXY AGAR)
K791477 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Sep 04, 1979
FLUID THIOGLYCOLLATE MEDIUM
K791478 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Sep 04, 1979
ENDO AGAR
K791479 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Sep 04, 1979
BIOLITE CARBON COATED DENTAL IMPLANT
K791491 · DZE
Carbomedics, Inc.
Dental · 29d
Cleared Sep 04, 1979
QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO
K791502 · KLB
Bio-Rad
Toxicology · 27d
Cleared Sep 04, 1979
AXIOM FILTERED CONNECTOR
K791508
Axiom Medical, Inc.
General & Plastic Surgery · 34d
Cleared Sep 04, 1979
AXIOM GASTRO SUMP DRAIN
K791509
Axiom Medical, Inc.
General & Plastic Surgery · 34d
Cleared Sep 04, 1979
ENZYMATIC REAGENT SET, 4X250 ML.
K791511 · CHH
Macomb Chemical Co.
Chemistry · 40d
Cleared Sep 04, 1979
SURELOC EXTERNAL CONNECTOR
K791532 · BZA
Polamedco, Inc.
Anesthesiology · 25d
Cleared Sep 04, 1979
ELECTROCARDIOGRAPH MODEL ECG-5403
K791540 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 25d
Cleared Sep 04, 1979
MODELS UL-804 AND BL-801 UNIPOLAR LEADS
K791552 · DTB
Pacesetter Systems
Cardiovascular · 21d
Cleared Sep 04, 1979
IL MODEL END TIDAL CO2 ANALYZER
K791570 · CCK
Instrumentation Laboratory CO
Anesthesiology · 22d
Cleared Sep 04, 1979
JELONET PARAFFIN GAUZE DRESSINGS
K791573 · FRO
Acme United Corp.
General & Plastic Surgery · 25d
Cleared Sep 04, 1979
CEREBRAL FUNCTION MONITOR 870
K791580 · OMA
Applied Medical Research
Neurology · 18d
Cleared Sep 04, 1979
GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN
K791605 · DEM
Protos Laboratories
Immunology · 15d
Cleared Sep 04, 1979
KWICK KOOLER
K791675 · IMD
Stahlex Corp.
Physical Medicine · 7d
Cleared Aug 28, 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · DJB
Abbott Laboratories
Microbiology · 263d
Cleared Aug 28, 1979
COMPUTERIZED ELECTRO-OCULOGRAPH
K790637 · HLX
Potomac Medical System
Ophthalmic · 148d
Cleared Aug 28, 1979
STAT
K790893 · HKP
Varian Assoc., Inc.
Ophthalmic · 112d
Cleared Aug 28, 1979
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101 · HBF
Codman & Shurtleff, Inc.
Neurology · 76d
Cleared Aug 28, 1979
ABCOR CARIES DETECTOR MONITOR
K791133 · LFC
Abcor, Inc.
Dental · 71d
Cleared Aug 28, 1979
APOLLO HEART RATE INDICATOR
K791207 · HCC
Key Tronic Corp.
Neurology · 57d
Cleared Aug 28, 1979
PYROLITE CARBON ENDOSSEOUS DENTAL IMPL
K791237 · DZE
Carbomedics, Inc.
Dental · 53d