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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39985–40008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2013
ELECTROMAGNETIC TRANSMITTING STYLET
K131532 · KNT
Corpak Medsystems
Gastroenterology & Urology · 76d
Cleared Aug 12, 2013
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
K131536 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 75d
Cleared Aug 12, 2013
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
K132197 · DQY
Pendracare International, B.V.
Cardiovascular · 27d
Cleared Aug 09, 2013
E-TENG MODEL EOR 1
K122562 · IPL
E-Teng Technology, Inc.
Physical Medicine · 352d
Cleared Aug 09, 2013
PROFTHAND MECHANICAL WHEELCHAIR
K123076 · IOR
Harmony Hill International
Physical Medicine · 312d
Cleared Aug 09, 2013
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · KCY
Zimmer, Inc.
General & Plastic Surgery · 263d
Cleared Aug 09, 2013
SUREFIX INTERSPINOUS FUSION SYSTEM
K124014 · PEK
Jg Spine, LLC
Orthopedic · 225d
Cleared Aug 09, 2013
CROSSTREES PVA POD
K130089 · NDN
Crosstrees Medical, Inc.
Orthopedic · 207d
Cleared Aug 09, 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
K130484 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 165d
Cleared Aug 09, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
K130685 · JFJ
Hitachi Chemical Diagnostics, Inc.
Chemistry · 149d
Cleared Aug 09, 2013
INTEL-GE CARE INNOVATIONS CONNECT RCM
K130821 · DRG
Intel-Ge Care Innovations, LLC
Cardiovascular · 137d
Cleared Aug 09, 2013
FACET SCREW SYSTEM
K130863 · MRW
Spinal USA
Orthopedic · 134d
Cleared Aug 09, 2013
ACCU-CHEK AVIVA PLUS TEST STRIP
K131029 · NBW
Roche Diagnostics Operations, Inc.
Chemistry · 119d
Cleared Aug 09, 2013
ARTHROCARE HEAD AND NECK COBLATION WAND
K131205 · GEI
ArthroCare Corporation
General & Plastic Surgery · 102d
Cleared Aug 09, 2013
ICONACY I-HIP SYSTEM
K131279 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 95d
Cleared Aug 09, 2013
LIVE VIEW PANEL (LVP)
K131415 · OLV
Neurotronics, Inc.
Neurology · 85d
Cleared Aug 09, 2013
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
K131419 · NBW
I-Sens, Inc.
Chemistry · 85d
Cleared Aug 09, 2013
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · LGD
DiaSorin, Inc.
Microbiology · 81d
Cleared Aug 09, 2013
CORE PEDICLE SCREW SYSTEM
K131522 · MNI
Core-Nexus
Orthopedic · 73d
Cleared Aug 09, 2013
PRODESSE PROFLU+ ASSAY
K132129 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 30d
Cleared Aug 09, 2013
CAPSURE PS SYSTEM
K132154 · MNI
Spine Wave, Inc.
Orthopedic · 28d
Cleared Aug 09, 2013
QLAB QUANTIFICATION SOFTWARE
K132165 · LLZ
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 09, 2013
METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
K132226 · HRS
Merete Medical GmbH
Orthopedic · 23d
Cleared Aug 08, 2013
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
K121610 · PDJ
Roche Diagnostics Operations
Chemistry · 433d