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
21097–21120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2020
FlowMet
K192966 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 79d
Cleared Jan 10, 2020
OsteoRemedies Hip Spacer System
K192995 · KWL
Osteoremedies, LLC
Orthopedic · 77d
Cleared Jan 10, 2020
CD Horizon™ Fenestrated Screw Set
K193011 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Jan 10, 2020
Univers Revers Modular Glenoid System (Augemented baseplates)
K193372 · PHX
Arthrex, Inc.
Orthopedic · 36d
Cleared Jan 10, 2020
MotoBAND CP Implant System
K193452 · HRS
Crossroads Extemity Systems, LLC
Orthopedic · 28d
Cleared Jan 10, 2020
CorticaLINK Spinal Fusion Platform
K193465 · NKB
Spine Smith Holdings, LLC
Orthopedic · 25d
Cleared Jan 09, 2020
HyaloGYN Vaginal Moisturizing Suppositories
K191052 · NUC
Fidia Farmaceutici S.P.A.
Obstetrics & Gynecology · 265d
Cleared Jan 09, 2020
Longeviti ClearFit Cranial Implant
K191210 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 248d
Cleared Jan 09, 2020
LED Curing Light
K192009 · EBZ
Ezgo Group, Inc.
Dental · 164d
Cleared Jan 09, 2020
Altapore
K192363 · MQV
Baxter Healthcare Corporation
Orthopedic · 132d
Cleared Jan 09, 2020
TrellOss™-L MPF
K192687 · MAX
Nexxt Spine, LLC
Orthopedic · 105d
Cleared Jan 09, 2020
Tyber Medical Trauma Screws
K192975 · HWC
Tyber Medical, LLC
Orthopedic · 77d
Cleared Jan 09, 2020
AMIStem-C
K193433 · LZO
Medacta International S.A.
Orthopedic · 30d
Cleared Jan 09, 2020
ER-REBOA PLUS Catheter
K193440 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 29d
Cleared Jan 08, 2020
Genesys Spine 3DP Cervical Interbody System
K191489 · OVE
Genesys Spine
Orthopedic · 218d
Cleared Jan 08, 2020
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic...
K191581 · OVD
Titan Spine, Inc.
Orthopedic · 208d
Cleared Jan 08, 2020
Clear Aligner
K192767 · NXC
Royal Dental Lab
Dental · 100d
Cleared Jan 08, 2020
Tyber Medical Trauma Screw
K192974 · HWC
Tyber Medical, LLC
Orthopedic · 76d
Cleared Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K193024 · JWY
Thermo Fisher Scientific
Microbiology · 70d
Cleared Jan 08, 2020
EASYGRIP FLO-41 Precision MIS Delivery System
K193137 · GCJ
Baxter Healthcare Corportation
General & Plastic Surgery · 56d
Cleared Jan 07, 2020
ERBECRYO 2 Cryosurgical Unit
K190651 · GEH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 300d
Cleared Jan 07, 2020
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
K190942 · LZA
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 272d
Cleared Jan 07, 2020
VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
K191870 · DRG
VivaLNK, Inc.
Cardiovascular · 179d
Cleared Jan 07, 2020
CRF Radiofrequency Ablation System
K192715 · GEI
Cambridge Interventional, LLC
General & Plastic Surgery · 102d