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
157945–157968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1983
SUTTER CPM 5000
K830974 · JFA
Sutter Biomedical, Inc.
Physical Medicine · 15d
Cleared Apr 11, 1983
NATURAL LOCK ACETABULAR COMPONENT
K830662 · JDL
Advanced Biosearch Assn.
Orthopedic · 39d
Cleared Apr 11, 1983
KODAK LANEX FAST SCREENS SO-470
K837201
Eastman Kodak Company
Radiology · 45d
Cleared Apr 11, 1983
KODAK ORTHO C FILM SO-344
K837202
Eastman Kodak Company
Radiology · 45d
Cleared Apr 11, 1983
DIGITAL SUBTRACTION ANGIOGRPAHY
K837252
Aster Medical, Inc.
Radiology · 47d
Cleared Apr 08, 1983
STERILE HD CVP TRAY
K823521 · FMF
Bill Dude Hospital Disposables, Inc.
General Hospital · 130d
Cleared Apr 08, 1983
REFEREE BRAND CO-OXIMETER REAGENTS
K830180 · KHG
Analytical Products, Inc.
Hematology · 80d
Cleared Apr 08, 1983
ARTIMICROBIAL REMOVAL DEVICE
K830372 · LJF
Marion Laboratories, Inc.
Microbiology · 63d
Cleared Apr 08, 1983
CYNOX I HEMOGLOBINOMETER
K830569 · JJQ
Buffalo Medical Specialties Mfg., Inc.
Hematology · 45d
Cleared Apr 08, 1983
BREATHING FILTER
K830618 · CAH
Ohio Medical Products
General Hospital · 39d
Cleared Apr 08, 1983
POLYSTYRENE MICROTITER PLATE IMMUNOSORB
K830653 · DGO
Diagnostic Reagent Tech.
Immunology · 38d
Cleared Apr 08, 1983
FIAX COMPLEMENT C4 TEST KIT
K830669 · DBI
Intl. Diagnostic Technology
Immunology · 35d
Cleared Apr 08, 1983
AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
K830680 · BSZ
Narco Scientific
Anesthesiology · 35d
Cleared Apr 08, 1983
DUPONT PREP TYPE CS EXTRACTION CARTRIDE
K830694
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared Apr 08, 1983
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · JSS
Abbott Laboratories
Microbiology · 32d
Cleared Apr 08, 1983
MINI LANCET-BLOOD LANCET
K830705 · FMA
Pharmaquest Corp.
General Hospital · 32d
Cleared Apr 08, 1983
NETILMICIN 30 MCG ANTIMICROBIAL DISK
K830731 · JTN
General Diagnostics
Microbiology · 31d
Cleared Apr 08, 1983
NETILMICIN 30 MCG SENSI DISC
K830732 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 31d
Cleared Apr 08, 1983
KOALA C99 I.V. CONTROLLER
K830780 · LDR
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 28d
Cleared Apr 08, 1983
VERI-STAPH
K830783 · JWX
Zeus Technologies
Microbiology · 28d
Cleared Apr 08, 1983
LEECO DIG-QUANT DIAG. TEST KIT
K830785
Leeco Diagnostics, Inc.
Chemistry · 28d
Cleared Apr 08, 1983
KNAI SODIUM POTASSIUM ANALYZER
K830805 · JSG
Radiometer America, Inc.
Chemistry · 25d
Cleared Apr 08, 1983
LEECO T3-RIA DIAGNOSTIC KIT
K830808 · CDP
Leeco Diagnostics, Inc.
Chemistry · 25d
Cleared Apr 08, 1983
S & W MODEL SW 37
K830874 · INQ
S & W Enterprises, Inc.
Physical Medicine · 21d