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
74209–74232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2002
FISHER DIAGNOSTICS THROMBOSCREEN 1000
K023362 · GKP
Fisher Diagnostics
Hematology · 63d
Cleared Dec 09, 2002
ACCESS TOTAL T4 ASSAY
K023369 · KLI
Beckman Coulter, Inc.
Chemistry · 62d
Cleared Dec 09, 2002
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · JFJ
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 09, 2002
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
K023550 · KNK
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 09, 2002
WIENER LAB GOT (AST) UV AA LIQUIDA
K023551 · CIT
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 06, 2002
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
K021548 · GEX
Fotona D.D.
General & Plastic Surgery · 207d
Cleared Dec 06, 2002
SPECTRUM CERVICAL SPINAL SYSTEM
K022997 · KWQ
Spinal Innovations, LLC
Orthopedic · 88d
Cleared Dec 06, 2002
BECTON DICKINSON DIABETES SOFTWARE
K023219 · NBW
Becton, Dickinson & CO
Chemistry · 71d
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281 · DIO
Roche Diagnostics Corp.
Toxicology · 66d
Cleared Dec 06, 2002
VITAL STIM
K023347 · IPF
Chattanooga Group
Physical Medicine · 60d
Cleared Dec 06, 2002
PORTA GEO TI
K023389 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Dec 06, 2002
AGC SPECIAL ALLOY
K023392 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Dec 06, 2002
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH...
K023577 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 44d
Cleared Dec 06, 2002
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON...
K023661 · JJY
Cliniqa Corporation
Chemistry · 36d
Cleared Dec 06, 2002
O.B. TAMPONS
K023789 · HEB
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 23d
Cleared Dec 06, 2002
MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
K023846 · GEI
Rita Medical Systems
General & Plastic Surgery · 17d
Cleared Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · LTK
Tosoh Medics, Inc.
Immunology · 14d
Cleared Dec 05, 2002
ASCENDENT ACETABULAR SYSTEM
K022985 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Dec 05, 2002
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K023007 · HRS
Hand Innovations, Inc.
Orthopedic · 87d
Cleared Dec 05, 2002
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K023716 · FRC
Spsmedical Supply Corp.
General Hospital · 30d
Cleared Dec 05, 2002
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
K023757 · GEH
Endocare, Inc.
General & Plastic Surgery · 27d
Cleared Dec 04, 2002
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489 · KRO
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Dec 04, 2002
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND...
K022048 · KWP
Interpore Cross Intl.
Orthopedic · 163d
Cleared Dec 04, 2002
TRANSONIC SYRINGE WARMER, MODEL SYR-1000
K022963 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 89d