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
75601–75624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2002
'RAPIDTEC' 5A MULTIPLE DIP TEST
K021114 · DKZ
American Bio Medica Corp.
Toxicology · 109d
Cleared Jul 23, 2002
PROLITE PULSED LIGHT SYSTEM
K021304 · GEX
Big Sky Laser Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 74d
Cleared Jul 23, 2002
MICROPAQ, MODELS 402, 404
K021681 · DRT
Welch Allyn Protocol, Inc.
Cardiovascular · 62d
Cleared Jul 23, 2002
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · CAW
Invacare Corp.
Anesthesiology · 62d
Cleared Jul 23, 2002
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · BTO
Rusch Intl.
Anesthesiology · 55d
Cleared Jul 23, 2002
R120 MODULAR TOTAL HIP SYSTEM
K021822 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 49d
Cleared Jul 23, 2002
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG...
K022046 · GGN
Vital Scientific N.V.
Hematology · 29d
Cleared Jul 23, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM
K022148 · KZE
Equidyne Systems, Inc.
General Hospital · 21d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171 · NBW
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jul 22, 2002
VECTORSONIC, MODEL VU-200
K020119 · IMG
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 189d
Cleared Jul 22, 2002
OPUS MAGNUM ANCHOR & INSTRUMENT SET
K020172 · MBI
Opus Medical, Inc.
Orthopedic · 186d
Cleared Jul 22, 2002
COLORADO 2 SPINAL SYSTEM
K020247 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 179d
Cleared Jul 22, 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 117d
Cleared Jul 22, 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313 · JWH
Aesculap, Inc.
Orthopedic · 88d
Cleared Jul 22, 2002
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
K021461 · KWQ
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Jul 22, 2002
CALIBRATING MATERIAL, BUFFERS, STANDARD
K022027 · JIT
Mission Diagnostics
Chemistry · 31d
Cleared Jul 22, 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · JHX
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jul 19, 2002
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
K011591 · ESW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 421d
Cleared Jul 19, 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · JLW
Awareness Technology, Inc.
Chemistry · 277d
Cleared Jul 19, 2002
KOLIBRI IGS SYSTEMS
K014256 · HAW
Brainlab AG
Neurology · 205d
Cleared Jul 19, 2002
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND...
K020910 · GXZ
The Electrode Store, Inc.
Neurology · 121d
Cleared Jul 19, 2002
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
K021279 · MHX
Datex-Ohmeda
Cardiovascular · 88d