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
19441–19464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2020
Adaptive Biotechnologies clonoSEQ Assay
K200009 · QDC
Adaptive Biotechnologies Corporation
Medical Genetics · 216d
Cleared Aug 05, 2020
PlasmaFlight
K200351 · IRP
Manamed, Inc.
Physical Medicine · 175d
Cleared Aug 05, 2020
XBit Series Digital Color Doppler Ultrasound System
K200780 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 133d
Cleared Aug 05, 2020
Modular Toga
K200977 · FYA
Operating Room Innovations, Inc.
General Hospital · 114d
Cleared Aug 05, 2020
Aurora® Anterior Lumbar Plate Sytstem
K201079 · KWQ
Prism Surgical Design Pty , Ltd.
Orthopedic · 105d
Cleared Aug 05, 2020
Mariner Cap System
K201240 · OWI
SeaSpine Orthopedics Corporation
Orthopedic · 89d
Cleared Aug 05, 2020
CarboClear Navigated Instruments
K201251 · OLO
CarboFix Orthopedics , Ltd.
Orthopedic · 86d
Cleared Aug 05, 2020
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K201530 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 58d
Cleared Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K201531 · LZA
Hartalega Sdn Bhd
General Hospital · 58d
Cleared Aug 05, 2020
Smart Toe II, X Fuse
K201715 · HTY
Stryker GmbH
Orthopedic · 43d
Cleared Aug 05, 2020
CrossGlide ETS Plus
K201952 · HHK
Crossbay Medical
Obstetrics & Gynecology · 22d
Cleared Aug 04, 2020
CureOs TCP
K191670 · MQV
Linacol Muh Dan Kim Cev Tek Med Ith...
Orthopedic · 410d
Cleared Aug 04, 2020
HYPER DLR
K193210 · KPS
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Aug 04, 2020
Corin Optimized Positioning System (OPS) Femoral
K193545 · LZO
Corin USA
Orthopedic · 228d
Cleared Aug 04, 2020
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy...
K193666 · LZA
Medline Industries, Inc.
General Hospital · 217d
Cleared Aug 04, 2020
ECG Monitor App
K201168 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 95d
Cleared Aug 04, 2020
HemoCue Hb 301 System
K201217 · GKR
Hemocue AB
Hematology · 90d
Cleared Aug 04, 2020
Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar...
K201500 · MAX
Life Spine, Inc.
Orthopedic · 60d
Cleared Aug 04, 2020
CoFix System
K201704 · PEK
Paradigm Spine GmbH
Orthopedic · 43d
Cleared Aug 04, 2020
Vector Hammertoe Correction System
K201850 · HWC
Nvision Biomedical Technologies, Inc.
Orthopedic · 29d
Cleared Aug 04, 2020
ETD Family of Electrotherapy Devices
K201958 · IPF
Therasigma, LLC
Physical Medicine · 21d
Cleared Aug 03, 2020
Attain Select II + SureValve delivery catheter system, Attain Command +...
K192712 · DQY
Medtronic, Inc.
Cardiovascular · 311d
Cleared Aug 03, 2020
Vesco Medical Extension Feeding Set
K192991 · PIF
Vesco Medical, LLC
Gastroenterology & Urology · 283d
Cleared Aug 03, 2020
Electrodes Handpieces for Mygen V-1000 RF System
K193355 · GEI
RF Medical Co., Ltd.
General & Plastic Surgery · 243d