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

Filters: Cleared only ×
176,076 results
80473–80496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · KHS
Dade Behring, Inc.
Chemistry · 52d
Cleared Mar 16, 2001
VISTAKON (HEFILCON C) CONTACT LENSES
K010218 · LPL
Vistakon
Ophthalmic · 51d
Cleared Mar 16, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K010223 · LPL
American Contact Lens, Inc.
Ophthalmic · 51d
Cleared Mar 16, 2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K010266 · NBC
Biosite Incorporated
Chemistry · 46d
Cleared Mar 16, 2001
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
K010287 · MOB
Scimedx Corp.
Immunology · 44d
Cleared Mar 16, 2001
MN-4 COARSE MANIPULATOR
K010298 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 44d
Cleared Mar 16, 2001
CBC-SF
K010409 · JPK
R&D Systems, Inc.
Hematology · 32d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Mar 16, 2001
SAFARI
K010606 · INI
Ranger All Season Corp.
Physical Medicine · 15d
Cleared Mar 16, 2001
ACCUSONIC, MODEL AS-260
K010609 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 15d
Cleared Mar 15, 2001
YORAMED, MODEL T-202
K002297 · GZJ
United Yoram Distributors, Inc.
Neurology · 230d
Cleared Mar 15, 2001
WISEBANDS SKIN CLOSURE DEVICE
K002315 · MKY
Wisebands , Ltd.
General & Plastic Surgery · 227d
Cleared Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · DAP
Sigma Diagnostics, Inc.
Hematology · 148d
Cleared Mar 15, 2001
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
K003301 · JOY
CellaVision AB
Hematology · 146d
Cleared Mar 15, 2001
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
K003344 · CAF
Medical Depot, Inc.
Anesthesiology · 141d
Cleared Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · CGA
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · JIT
Dade Behring, Inc.
Chemistry · 122d
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · LDJ
ACON Laboratories, Inc.
Toxicology · 118d
Cleared Mar 15, 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
K003899 · LNH
Mri Devices Corp.
Radiology · 87d
Cleared Mar 15, 2001
LASEREX INTEGRE, MODEL LP2532
K003955 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 84d
Cleared Mar 15, 2001
PANASONIC TELE-HOMECARE SYSTEM
K004050 · MWI
Matsushita Electric Industrial Co., Ltd.
Cardiovascular · 76d
Cleared Mar 15, 2001
ULTRAPAK NEHA
K010070 · MVL
Ultradent Products, Inc.
Dental · 66d
Cleared Mar 15, 2001
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · OMB
Excel Tech. , Ltd.
Neurology · 63d
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103 · FPA
Terumo Medical Corp.
General Hospital · 62d