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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
45673–45696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2011
PICO
K111170 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 233d
Cleared Dec 15, 2011
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
K111669 · LZG
Insulet Corporation
General Hospital · 183d
Cleared Dec 15, 2011
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
K111746 · KWT
Biomet, Inc.
Orthopedic · 177d
Cleared Dec 15, 2011
ARTHREX BIOCOMPOSITE TRANSFIX
K112040 · MAI
Arthrex, Inc.
Orthopedic · 150d
Cleared Dec 15, 2011
ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS
K112218 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 135d
Cleared Dec 15, 2011
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
K112275 · NBW
Taidoc Technology Corporation
Chemistry · 129d
Cleared Dec 15, 2011
QUIDEL MOLECULAR HMPV ASSAY
K112490 · OEM
Quidel Corp.
Microbiology · 108d
Cleared Dec 15, 2011
APTUS(R) DISTAL HUMERUS SYSTEM
K112560 · HRS
Medartis AG
Orthopedic · 104d
Cleared Dec 15, 2011
BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
K112562 · OYI
Kimberly-Clark
Anesthesiology · 80d
Cleared Dec 15, 2011
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K112780 · JWH
Conformis, Inc.
Orthopedic · 80d
Cleared Dec 15, 2011
CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK...
K112876 · MBI
Cayenne Medical, Inc.
Orthopedic · 76d
Cleared Dec 15, 2011
TEMPUSIC PATIENT MONITOR
K113105 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 56d
Cleared Dec 15, 2011
MSA HIP SYSTEM
K113107 · MEH
Global Manufacturing Technology
Orthopedic · 56d
Cleared Dec 15, 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7...
K113133 · DXT
Medrad, Inc.
Cardiovascular · 52d
Cleared Dec 15, 2011
ROG SUTURE ANCHOR
K113299 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 37d
Cleared Dec 15, 2011
EXSALT T7 WOUND DRESSING
K113564 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 13d
Cleared Dec 14, 2011
PSM LOMAS / BENEFIT SCREWS
K110392 · OAT
Psm Medical Solutions
Dental · 306d
Cleared Dec 14, 2011
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
K111313 · FQH
Alcavis Hdc, LLC
General Hospital · 218d
Cleared Dec 14, 2011
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
K111738 · DQY
Trireme Medical, Inc.
Cardiovascular · 176d
Cleared Dec 14, 2011
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL,...
K111753 · CHH
Hitachi Chemical Diagnostics, Inc.
Chemistry · 175d
Cleared Dec 14, 2011
KDL SYRINGES AND NEEDLE
K112057 · FMF
Shanghai Kindly Enterprise Dev. Group...
General Hospital · 148d
Cleared Dec 14, 2011
TAPERED SCREW-VENT X IMPLANT
K112160 · DZE
Zimmer Dental, Inc.
Dental · 140d
Cleared Dec 14, 2011
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT...
K112203 · DRS
Mirador Biomedical, Inc.
Cardiovascular · 135d
Cleared Dec 14, 2011
4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
K112316 · MAX
4-Web, Inc.
Orthopedic · 125d