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
77641–77664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 2001
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
K013556 · FOZ
Tyco Healthcare
General Hospital · 67d
Cleared Dec 31, 2001
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
K013942 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 32d
Cleared Dec 31, 2001
STRYKER PAINPUMP
K014091 · FRN
Stryker Corp.
General Hospital · 19d
Cleared Dec 28, 2001
MAGNETOM TRIO SYSTEM
K013586 · LNH
Siemens Medical Systems, Inc.
Radiology · 59d
Cleared Dec 28, 2001
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
K013721 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 49d
Cleared Dec 27, 2001
SPINAL MESH SYSTEM
K011406 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 233d
Cleared Dec 27, 2001
KIMSTIM AURICULAR ELECTRODE
K011691 · GXY
Kim Institute For Rehabilitation...
Neurology · 210d
Cleared Dec 27, 2001
AVALON CUP SYSTEM
K011887 · JDI
Orthopedic Source, Inc.
Orthopedic · 192d
Cleared Dec 27, 2001
FOTONA DUALIS, FOTONA DUALIS PLUS
K011939 · GEX
Fotona D.D.
General & Plastic Surgery · 189d
Cleared Dec 27, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
K012183 · LGD
Bayer Diagnostics Corp.
Microbiology · 168d
Cleared Dec 27, 2001
BIOTEQUE VAGINAL PESSARIES
K013289 · HHW
Bioteque America, Inc.
Obstetrics & Gynecology · 86d
Cleared Dec 27, 2001
LONG TROCHANTERIC NAIL SYSTEM
K013563 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d
Cleared Dec 27, 2001
VICTORCH MEDITEK'S HCG TEST CARD
K013678 · DHA
Victorch Meditek, Inc.
Chemistry · 50d
Cleared Dec 27, 2001
VICTORCH HCG TEST STRIP
K013702 · JHI
Victorch Meditek, Inc.
Chemistry · 49d
Cleared Dec 27, 2001
D902 PH.I.S.I.O OXYGENATOR
K013915 · DTZ
Dideco S.P.A.
Cardiovascular · 30d
Cleared Dec 27, 2001
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR...
K013991 · JWH
Zimmer, Inc.
Orthopedic · 23d
Cleared Dec 27, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 16d
Cleared Dec 26, 2001
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK...
K011589 · NCA
Bypass , Ltd.
General & Plastic Surgery · 217d
Cleared Dec 26, 2001
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K012731 · LPN
Ciba Vision Corporation
Ophthalmic · 133d
Cleared Dec 26, 2001
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
K013225 · KMF
Medafor, Inc.
General & Plastic Surgery · 90d
Cleared Dec 26, 2001
OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
K013445 · LPL
Florida Optical Engineering, Inc.
Ophthalmic · 70d
Cleared Dec 26, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · DAP
Sigma Diagnostics, Inc.
Hematology · 63d
Cleared Dec 26, 2001
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
K013591 · EOB
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 57d
Cleared Dec 26, 2001
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
K013649 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 51d