FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76513–76536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2002
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS
K014182 · ITX
Tetrad Corp.
Radiology · 14d
Cleared Jan 02, 2002
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
K003689 · IXK
Canon USA, Inc.
Radiology · 398d
Cleared Jan 02, 2002
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
K013304 · DBY
Becton Dickinson Infusion Therapy...
Immunology · 90d
Cleared Jan 02, 2002
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K013514 · MOS
Mri Devices Corp.
Radiology · 72d
Cleared Dec 31, 2001
MSI BIPOLAR SHEATH
K011202 · HRX
Medical Scientific, Inc.
Orthopedic · 256d
Cleared Dec 31, 2001
REMEDY MODEL 2Z12
K012029 · KMG
Apollo Corp.
General Hospital · 186d
Cleared Dec 31, 2001
AUROPAL, ORDER-NO.: 2101
K012839 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 130d
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