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
18673–18696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2020
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
K202317 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 88d
Cleared Nov 13, 2020
Stryker Omega PEEK Knotless Anchor System
K202355 · MBI
Stryker
Orthopedic · 86d
Cleared Nov 13, 2020
APEX 3D Total Ankle Replacement System
K202373 · HSN
Paragon 28, Inc.
Orthopedic · 86d
Cleared Nov 13, 2020
FlexCath Advance Steerable Sheath and Dilator
K202620 · DRA
Medtronic Cryocath, LP
Cardiovascular · 64d
Cleared Nov 13, 2020
SIGNA Architect
K202966 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 44d
Cleared Nov 13, 2020
Monster Screw System
K203011 · HWC
Paragon 28, Inc.
Orthopedic · 43d
Cleared Nov 13, 2020
TSolution One Total Knee Application
K203040 · OLO
THINK Surgical, Inc.
Orthopedic · 38d
Cleared Nov 12, 2020
AGILON® XO Shoulder Replacement System
K191433 · HSD
Implantcast GmbH
Orthopedic · 533d
Cleared Nov 12, 2020
EOGas 4 Ethylene Oxide Gas Sterilizer
K192978 · FLF
Andersen Sterilizers, Inc.
General Hospital · 385d
Cleared Nov 12, 2020
EOGas 4 Endo-SteriTest
K192980 · FRC
Andersen Sterilizers, Inc.
General Hospital · 385d
Cleared Nov 12, 2020
FastStroke, CT Perfusion 4D
K193289 · JAK
GE Medical Systems SCS
Radiology · 351d
Cleared Nov 12, 2020
TP Orthodontics Clear Aligner System
K193385 · NXC
Tp Orthodontics, Inc.
Dental · 342d
Cleared Nov 12, 2020
O2asis Personal Oxygen Humidifier
K193411 · BTT
Perma Pure, LLC
Anesthesiology · 339d
Cleared Nov 12, 2020
AN1036 Dosimeter
K200334 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
Sterisheet Sterilization Wrap
K200335 · FRG
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
Tyvek Sterilization Pouches with Chevron Seal
K200336 · FRG
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
Sharps container
K201523 · MMK
Zhejiang Gongdong Medical Technology...
General Hospital · 157d
Cleared Nov 12, 2020
Calvary Spine Pedicle Screw System
K201568 · NKB
Calvary Spine, LLC
Orthopedic · 154d
Cleared Nov 12, 2020
KardiaAI
K201985 · DQK
AliveCor, Inc.
Cardiovascular · 118d
Cleared Nov 12, 2020
Apache Ultrasound System (Model C62)
K202074 · IYN
Compal Electronics, Inc.
Radiology · 108d
Cleared Nov 12, 2020
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and...
K202571 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 69d
Cleared Nov 12, 2020
Insight Infrared Video Goggles
K203082 · GWN
Vestibular First
Ear, Nose, Throat · 30d
Cleared Nov 12, 2020
NOVA Patient Warming System
K203085 · DWJ
Encompass Group, LLC
Cardiovascular · 30d
Cleared Nov 12, 2020
ExacTrac Dynamic
K203173 · IYE
Brainlab AG
Radiology · 17d