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
68065–68088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2004
HYPROCURE SUBTALAR IMPLANT SYSTEM
K042030 · HWC
Graham Medical Technologies, LLC
Orthopedic · 50d
Cleared Sep 16, 2004
CALLOS CMF BONE VOID FILLER
K042072 · GXP
Skeletal Kinetics, LLC
Neurology · 45d
Cleared Sep 16, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS...
K042195 · LBS
Beckman Coulter, Inc.
Chemistry · 34d
Cleared Sep 16, 2004
XLTEK CONNEX IP HEADBOX, MODEL 1054
K042223 · OMB
Excel Tech. , Ltd.
Neurology · 30d
Cleared Sep 16, 2004
EBI PERIARTICULAR PLATING SYSTEM
K042237 · HRS
Ebi, L.P.
Orthopedic · 29d
Cleared Sep 16, 2004
CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
K042238 · LZA
Seal Polymer Industries Bhd.
General Hospital · 29d
Cleared Sep 16, 2004
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
K042244 · HWC
Triage Medical, Inc.
Orthopedic · 28d
Cleared Sep 16, 2004
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
K042281 · JLW
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Sep 16, 2004
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
K042295 · HWC
Linvatec Biomaterials, Ltd.
Orthopedic · 23d
Cleared Sep 16, 2004
ORTHO-PRO CANNULATED BONE SCREWS
K042310 · HWC
Ortho-Pro, LLC
Orthopedic · 22d
Cleared Sep 16, 2004
ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
K042326 · IYN
Ultrasonix Medical Corporation
Radiology · 20d
Cleared Sep 16, 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 17d
Cleared Sep 16, 2004
THE PRODIGY SYSTEM DENTAL IMPLANTS
K042429 · DZE
BioHorizons Implant Systems, Inc.
Dental · 8d
Cleared Sep 15, 2004
EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
K033634 · KWA
Centerpulse Orthopedics, Inc.
Orthopedic · 301d
Cleared Sep 15, 2004
VST3
K040942 · DXH
Biowatch Medical, Inc.
Cardiovascular · 156d
Cleared Sep 15, 2004
EPITOME SYSTEM
K041206 · HNO
Gebauer Medizintechnik GmbH
Ophthalmic · 131d
Cleared Sep 15, 2004
CD HORIZON SPINAL SYSTEM
K041862 · KWP
Medtronic Sofamor Danek
Orthopedic · 68d
Cleared Sep 15, 2004
DISPOSABLE MONITORING ELECTRODES
K041954 · DRX
Shanghai Intco Electrode...
Cardiovascular · 57d
Cleared Sep 15, 2004
SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)
K042020 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 50d
Cleared Sep 15, 2004
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
K042194 · DQY
Medtronic Vascular
Cardiovascular · 34d
Cleared Sep 15, 2004
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
K042214 · LYZ
Shandong Perfect Plastic Co., Ltd.
General Hospital · 30d
Cleared Sep 15, 2004
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
K042242 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 27d
Cleared Sep 15, 2004
CLS SPOTORNO STEM
K042249 · LZO
Zimmer Austin, Inc.
Orthopedic · 27d
Cleared Sep 15, 2004
MDI ORTHO
K042289 · DZE
Imtec Corp.
Dental · 22d