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
14929–14952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2022
Treace Medical Concepts (TMC) Plating System
K220136 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 29d
Cleared Feb 16, 2022
Aspiron S ACP System
K220147 · KWQ
U&I Corporation
Orthopedic · 28d
Cleared Feb 16, 2022
Apapro Desensitizer
K220419 · LBH
Sangi Co, Ltd.
Dental · 2d
Cleared Feb 15, 2022
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
K203234 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 469d
Cleared Feb 15, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K210229 · MEG
Zhejiang Kangkang Medical-Devices...
General Hospital · 383d
Cleared Feb 15, 2022
Morpheus
K210636 · LRK
S4S UK , Ltd.
Dental · 361d
Cleared Feb 14, 2022
RithmID-SD Steerable Diagnostic Electrophysiology Catheter
K203793 · DRF
Synaptic Medical Corporation
Cardiovascular · 413d
Cleared Feb 14, 2022
Fogarty Occlusion Catheter
K211610 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared Feb 14, 2022
Vinyl Powder Free Examination Glove
K212011 · LYZ
Top Glove Vietnam Company Limited
General Hospital · 231d
Cleared Feb 14, 2022
EvoEndo Single-Use Endoscopy System
K213606 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 14, 2022
Cionic Neural Sleeve NS-100
K213622 · GZI
Cionic
Neurology · 90d
Cleared Feb 11, 2022
PainTB, PainTJ
K203337 · NHN
Ptech Co., Ltd.
Physical Medicine · 456d
Cleared Feb 11, 2022
Electric Breast Pump
K211024 · HGX
Shantou Huihengqi Electronic...
Obstetrics & Gynecology · 311d
Cleared Feb 11, 2022
ArtUs
K211248 · IYN
Telemed
Radiology · 291d
Cleared Feb 11, 2022
Pulse Oximeter
K211400 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 282d
Cleared Feb 11, 2022
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating...
K211712 · KWQ
Orthofix US, LLC
Orthopedic · 253d
Cleared Feb 11, 2022
Wearable Breast Pump (Model S12)
K212180 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Feb 11, 2022
FlexitSystem Knee osteotomy system
K212545 · HRS
Neosteo
Orthopedic · 183d
Cleared Feb 11, 2022
OsteoPlan System
K212570 · DZJ
Osteomed, LLC
Dental · 179d
Cleared Feb 11, 2022
Zyter RPM
K212622 · MSX
Zyter, Inc.
Cardiovascular · 177d
Cleared Feb 11, 2022
Actively Trying Personal Lubricant Rose Scented
K212885 · PEB
CC Wellness, LLC
Obstetrics & Gynecology · 154d
Cleared Feb 11, 2022
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
K213328 · HSB
Stryker GmbH
Orthopedic · 129d
Cleared Feb 11, 2022
EzRay M18 (Model: VMX-P400)
K213462 · IZL
VATECH Co., Ltd.
Radiology · 107d
Cleared Feb 11, 2022
ACUSON P500 Ultrasound System
K213487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 105d