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
29377–29400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2017
Soft Plug Extended Duration 180 Canalicular Plug
K162361 · LZU
Oasis Medical, Inc.
Ophthalmic · 237d
Cleared Apr 17, 2017
Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra...
K162621 · IOR
Invacare Corporation
Physical Medicine · 209d
Cleared Apr 17, 2017
PowerFlow Apheresis I.V. Port
K163001 · PTD
C.R. Bard, Inc.
General Hospital · 171d
Cleared CT Apr 17, 2017
Paxman Scalp Cooler
K163484 · PMC
Paxman Coolers Limited
General & Plastic Surgery · 126d
Cleared Apr 17, 2017
EndoFLIP® System with FLIP Topography module
K170833 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 28d
Cleared Apr 14, 2017
GMK UNI
K161741 · HSX
Medacta International S.A.
Orthopedic · 294d
Cleared Apr 14, 2017
Etgar Dental Implant System
K161743 · DZE
Etgar Medical Instruments, Ltd.
Dental · 294d
Cleared Apr 14, 2017
CENTURION Vision System (Active SentryTM)
K161794 · HQC
Alcon Research, Ltd.
Ophthalmic · 288d
Cleared Apr 14, 2017
Smart Dongle Blood Glucose Monitoring System
K162382 · NBW
Taidoc Technology Corporation
Chemistry · 233d
Cleared Apr 14, 2017
Sofia Influenza A+B FIA on Sofia 2
K162438 · PSZ
Quidel Corporation
Microbiology · 226d
Cleared Apr 14, 2017
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K162517 · NUH
Jkh Health Co., Ltd.
Neurology · 217d
Cleared Apr 14, 2017
Marco Ultra M3, Marco Ultra M4
K162636 · HJO
Takagi Seiko Co., Ltd.
Ophthalmic · 205d
Cleared Apr 14, 2017
Velox Nebulizer System
K162785 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 193d
Cleared Apr 14, 2017
Complete Control System
K162891 · GXY
Coapt, LLC
Neurology · 179d
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