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
13513–13536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2022
CorPath GRX System
K221464 · DXX
Corindus, Inc.
Cardiovascular · 69d
Cleared Jul 27, 2022
Pegasus-X Expandable PLIF System
K221687 · MAX
GS Medical Co., Ltd.
Orthopedic · 47d
Cleared Jul 27, 2022
OTC DDR
K221853 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 30d
Cleared Jul 27, 2022
BIOMONITOR IIIm, BIOMONITOR III
K221856 · MXD
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jul 26, 2022
Gastric Lightguide (GLG)
K212407 · KNT
Naser Dib Gabinet Lekarksi Nasmed
Gastroenterology & Urology · 357d
Cleared Jul 26, 2022
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K213858 · NXO
DiaSorin, Inc.
Immunology · 228d
Cleared Jul 26, 2022
Invia Ease Negative Pressure Wound Therapy (NPWT) System
K214112 · OMP
Medela AG
General & Plastic Surgery · 208d
Cleared Jul 26, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
K221404 · JWH
Conformis, Inc.
Orthopedic · 71d
Cleared Jul 26, 2022
Parcus Synd-EZ SS
K221502 · MBI
Parcus Medical, LLC
Orthopedic · 64d
Cleared Jul 26, 2022
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
K221567 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 56d
Cleared Jul 26, 2022
VyPlate Anterior Cervical Plate System
K221572 · KWQ
Vy Spine, LLC
Orthopedic · 55d
Cleared Jul 26, 2022
Cemented Round Patella with JRNY Pegs
K221939 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Jul 25, 2022
Viz SDH
K220439 · QAS
Viz. Ai, Inc.
Radiology · 159d
Cleared Jul 25, 2022
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
K220606 · EOQ
Ambu A/S
Ear, Nose, Throat · 145d
Cleared Jul 25, 2022
Tigertriever 13 Revascularization Device
K220808 · NRY
Rapid Medical , Ltd.
Neurology · 129d
Cleared Jul 25, 2022
Paneffort 3-ply Surgical and Procedural Masks
K221409 · FXX
Paneffort, LLC
General Hospital · 70d
Cleared Jul 25, 2022
BioFire COVID-19 Test 2
K221460 · QQX
Biofire Defense, LLC
Microbiology · 67d
Cleared Jul 23, 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
K221877 · LZA
Goodgloves Industries Sdn Bhd
General Hospital · 25d
Cleared Jul 22, 2022
BioFire JI Control Panel M420
K203680 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 582d
Cleared Jul 22, 2022
BLUE 400
K211346 · QFX
Carl Zeiss Meditec, AG
Neurology · 445d
Cleared Jul 22, 2022
Sterile Level 3 Surgical Gown
K211399 · FYA
Barco Tekstil Sanayi VE Ticaret A.S.
General Hospital · 443d
Cleared Jul 22, 2022
DM Converter - TiN coated
K211891 · LZO
Medacta International S.A.
Orthopedic · 396d
Cleared Jul 22, 2022
MedWand
K212975 · MWI
Medwand Solutions, Inc.
Cardiovascular · 308d
Cleared Jul 22, 2022
DuraFuse Clip and Applier System
K213813 · FZP
Neuramedica, Inc.
General & Plastic Surgery · 227d