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
28801–28824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2017
CeraClean
K163171 · PME
Bisco, Inc.
Dental · 151d
Cleared Apr 14, 2017
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
K163329 · OHS
Pulsaderm, LLC
General & Plastic Surgery · 137d
Cleared Apr 14, 2017
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
K163381 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 134d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 115d
Cleared Apr 14, 2017
Hoffmann LRF System
K163656 · KTT
Stryker GmbH
Orthopedic · 112d
Cleared Apr 14, 2017
Threshold™ Pedicular Fixation System
K170251 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Threshold™ V2 Pedicular Fixation System
K170255 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Palisade™ Pedicular Fixation System
K170266 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Fortress™ Pedicular Fixation System
K170268 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Saf-T-Vac Smoke and Fluid Evacuator
K170582 · GEI
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 45d
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 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