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
75001–75024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2002
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
K022224 · DYH
Coltene AG
Dental · 70d
Cleared Sep 18, 2002
BIOPORTA SOLDER 1020
K022462 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 54d
Cleared Sep 18, 2002
ECO E4
K022469 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 54d
Cleared Sep 18, 2002
PORTA SOLDER 1080 W
K022470 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 54d
Cleared Sep 18, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K022744 · HWE
Medical Device Services
Orthopedic · 30d
Cleared Sep 18, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 17, 2002
SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
K020464 · ILY
Rolor Electronics Corp.
Physical Medicine · 217d
Cleared Sep 17, 2002
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
K020583 · MHI
Ivd Research, Inc.
Microbiology · 208d
Cleared Sep 17, 2002
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
K021057 · MSW
Brahms Diagnostica, LLC
Immunology · 169d
Cleared Sep 17, 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · KWQ
Medtronic Sofamor Danek
Orthopedic · 111d
Cleared Sep 17, 2002
OEC FLUOROTRAK 9800 PLUS
K022069 · OWB
Ge Oec Medical Systems
Radiology · 84d
Cleared Sep 17, 2002
IMPERIUM
K022114 · OWB
Elmstech, Inc.
Radiology · 81d
Cleared Sep 17, 2002
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
K022163 · DQA
Welch Allyn, Inc.
Anesthesiology · 76d
Cleared Sep 17, 2002
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
K022324 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 17, 2002
POCKETCHEM UA AUTION STICKS 10TA
K022386 · JIL
Arkray, Inc.
Chemistry · 57d
Cleared Sep 17, 2002
EXTERNAL FIXATION RING
K022423 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 55d
Cleared Sep 17, 2002
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 54d
Cleared Sep 17, 2002
PORTA IP SOLDER V-1
K022456 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
PORTA OPTIMUM SOLDER 710
K022457 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
PORTA IP SOLDER V-2
K022467 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
PORTA OPTIMUM SOLDER 900
K022468 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
BIOMET CALCANEAL PLATE
K022515 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 49d
Cleared Sep 17, 2002
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
K022701 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Sep 17, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
K022758 · JJX
Cliniqa Corporation
Chemistry · 28d