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
39745–39768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2013
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE...
K132324 · KWQ
Medos International SARL
Orthopedic · 42d
Cleared Sep 06, 2013
THERMAGE CPT SYSTEM
K132431 · GEI
Solta Medical, Inc.
General & Plastic Surgery · 32d
Cleared Sep 05, 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K123723 · GWO
Synthes
Neurology · 275d
Cleared Sep 05, 2013
STITCHKIT
K123811 · NBY
Origami Surgical, LLC
General & Plastic Surgery · 268d
Cleared Sep 05, 2013
KOSTEC MEDICAL GRADE LDC MONITORS
K123944 · LLZ
Kostec Co., Ltd.
Radiology · 259d
Cleared Sep 05, 2013
ARIX FOOT SYSTEM
K131311 · HRS
Jeil Medical Corporation
Orthopedic · 121d
Cleared Sep 05, 2013
PRESSUREWIRE
K131452 · DXO
St. Jude Medical Systems AB
Cardiovascular · 108d
Cleared Sep 05, 2013
Z5MLB, Z5MLC
K131701 · DZE
Z-Systems AG
Dental · 86d
Cleared Sep 05, 2013
ACUMED WRIST SPANNING PLATE
K131764 · HRS
Acumed, LLC
Orthopedic · 80d
Cleared Sep 05, 2013
TEPHAFLEX BRAIDED SUTURE
K132348 · NWJ
Tepha, Inc.
General & Plastic Surgery · 38d
Cleared Sep 05, 2013
LIAISON 25 TOTAL-D
K132492 · MRG
DiaSorin, Inc.
Chemistry · 27d
Cleared Sep 04, 2013
INTEGRA INTERSPINOUS PROCESS SYSTEM
K121924 · PEK
Seaspine, Inc.
Orthopedic · 429d
Cleared Sep 04, 2013
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
K131044 · DQD
Diacoustic Medical Devices (Pty) , Ltd.
Cardiovascular · 142d
Cleared Sep 04, 2013
BIOSPACE
K131064 · DXN
Biospace Corporation Limited
Cardiovascular · 141d
Cleared Sep 04, 2013
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
K131148 · DYB
Access Scientific, LLC
Cardiovascular · 134d
Cleared Sep 04, 2013
POLARIS SPINAL SYSTEM
K131615 · OSH
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 93d
Cleared Sep 04, 2013
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
K131980 · NKB
Zimmer Spine, Inc.
Orthopedic · 68d
Cleared Sep 04, 2013
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
K132045 · KPQ
Ge Hungary Kft
Radiology · 64d
Cleared Sep 04, 2013
5MP GRAYSCALE LCD DISPLAY
K132610 · LLZ
Shenzhen Beacon Display Technology...
Radiology · 15d
Cleared Sep 03, 2013
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS...
K123907 · KRR
Biomet Manufacturing Corp
Orthopedic · 258d
Cleared Sep 03, 2013
RESURFX 1565NM LASER MODULE
K130028 · ONG
Lumenis, Ltd.
General & Plastic Surgery · 243d
Cleared Sep 03, 2013
ARDIS INTERBODY SYSTEM
K131242 · MAX
Zimmer Spine, Inc.
Orthopedic · 125d
Cleared Sep 03, 2013
VARILIFT-L INTERBODY FUSION DEVICE
K131296 · MAX
Wenzel Spine, Inc.
Orthopedic · 120d
Cleared Sep 03, 2013
INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
K131540 · MAX
Vertebral Technologies, Inc.
Orthopedic · 97d