FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29401–29424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2017
Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
K170643 · MAX
Rti Surgical, Inc. Dba Rti Biologics
Orthopedic · 43d
Cleared Apr 13, 2017
Intelli-Ox
K161179 · ECX
Air Liquide Healthcare America...
Anesthesiology · 352d
Cleared Apr 13, 2017
MICATM Screw System
K162353 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Apr 13, 2017
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope...
K162447 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 224d
Cleared Apr 13, 2017
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS...
K163269 · OVD
Titan Spine, LLC
Orthopedic · 143d
Cleared Apr 13, 2017
Interson USB Ultrasound System
K163443 · IYN
Interson Corporation
Radiology · 126d
Cleared CT Apr 13, 2017
Coolief* Cooled RF Probe
K163461 · GXI
Halyard Health, Inc.
Neurology · 125d
Cleared Apr 13, 2017
CAPRI Corpectomy Cage System
K170055 · MQP
K2m
Orthopedic · 97d
Cleared Apr 13, 2017
Additive Orthopaedics Locking Lattice Plate
K170214 · HRS
Additive Orthopaedics, LLC
Orthopedic · 79d
Cleared Apr 13, 2017
Patient Positioning System
K170502 · JAI
Forte Automation Systems, Inc.
Radiology · 51d
Cleared Apr 13, 2017
PlasmaBlade T
K170610 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 43d
Cleared Apr 12, 2017
HIGH V+
K161114 · NDN
Teknimed Sas
Orthopedic · 357d
Cleared Apr 12, 2017
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth...
K163355 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 133d
Cleared Apr 12, 2017
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin...
K170386 · FMF
Becton, Dickinson Company
General Hospital · 63d
Cleared Apr 11, 2017
Nova Max Uric Acid Monitoring System
K160990 · PTC
Nova Biomedical Corporation
Chemistry · 368d
Cleared Apr 11, 2017
MINNE TIES MMF Suture System
K162046 · DYX
Summit Medical, Inc.
Dental · 260d
Cleared Apr 11, 2017
HAAG-STREIT FUNDUS MODULE 300
K163021 · HKI
Optomed OY
Ophthalmic · 162d
Cleared Apr 11, 2017
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
K163547 · GXY
Neurovirtual USA, Inc.
Neurology · 116d
Cleared Apr 11, 2017
REMbrandt
K163617 · OLZ
Embla Systems
Neurology · 110d
Cleared Apr 11, 2017
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
K163698 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 103d
Cleared Apr 11, 2017
LOGIQ S8
K170445 · IYN
Ge Healthcare
Radiology · 56d
Cleared Apr 11, 2017
Bausch + Lomb Sensitive Eyes Plus Saline Solution
K170483 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 54d
Cleared CT Apr 11, 2017
Carestream Vue PACS
K170580 · LLZ
Carestream Health, Inc.
Radiology · 42d
Cleared Apr 11, 2017
CyberKnife Treatment Delivery System
K170788 · IYE
Accuray Incorportaed
Radiology · 26d