FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89977–90000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1998
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
K980463 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
QUICK-CUT AUTOMATIC BIOPSY SYSTEM
K980479 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 89d
Cleared May 06, 1998
CHARGER (ED)
K980567 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 82d
Cleared May 06, 1998
VSS, VIRTUAL SIMULATION SYSTEM
K980629 · IYE
Nucletron Corp.
Radiology · 77d
Cleared May 06, 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE...
K980646 · MQM
Instrumentation Laboratory CO
Chemistry · 76d
Cleared May 06, 1998
VR NETSERVE
K980684 · LMD
I.S.G. Technologies, Inc.
Radiology · 72d
Cleared May 06, 1998
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
K980715 · KPS
Adac Laboratories
Radiology · 71d
Cleared May 06, 1998
XTEND
K980752 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 75d
Cleared May 06, 1998
FACTS MONOBLOCK
K981267 · IZX
Dynarad Corp.
Radiology · 29d
Cleared May 05, 1998
EXEL AVF SINGLE NEEDLE
K963658 · FMI
Exel Intl.
General Hospital · 609d
Cleared May 05, 1998
OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
K972020 · DXW
Cas Medical Systems, Inc.
Cardiovascular · 337d
Cleared May 05, 1998
BIOMET BIAXIAL TOTAL ELBOW
K980428 · JDC
Biomet, Inc.
Orthopedic · 90d
Cleared May 05, 1998
JOBST ATHROMBIC PUMP SYSTEM 2600
K980456 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 89d
Cleared May 05, 1998
ONPLANT ORTHODONTIC SYSTEM
K980460 · DZE
Nobel Biocare Uas, Inc.
Dental · 92d
Cleared May 05, 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · JDC
Osteonics Corp.
Orthopedic · 85d
Cleared May 05, 1998
OSTEONICS FX-CABLELOK GRIP COMPONENTS
K980594 · LYT
Osteonics Corp.
Orthopedic · 77d
Cleared May 04, 1998
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T...
K980417 · LNH
Medrad, Inc.
Radiology · 90d
Cleared May 04, 1998
LIGHTSHEER
K980420 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared May 04, 1998
SYNTEC VITMAN
K980480 · HQC
Syntec, Inc.
Ophthalmic · 90d
Cleared May 04, 1998
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · GAW
Aesculap, Inc.
General & Plastic Surgery · 70d
Cleared May 04, 1998
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
K980777 · FRO
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 63d
Cleared May 04, 1998
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
K980827 · LZB
Tucker & Associates
General Hospital · 62d
Cleared May 01, 1998
GLASS VAN GLASS SYRINGES
K963364 · FMF
Myco Medical Supplies, Inc.
General Hospital · 613d
Cleared May 01, 1998
B-D ASSURE EAR THERMOMETER
K971994 · FLL
Becton Dickinson Consumer Products
General Hospital · 337d