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
16873–16896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2021
Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face...
K203347 · BZD
Suzhou Yuyue Medical Technology Co.,...
Anesthesiology · 231d
Cleared Jul 02, 2021
The Alma Hybrid Laser System
K203441 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 221d
Cleared Jul 02, 2021
LX9max
K203498 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 217d
Cleared Jul 02, 2021
Single-use Medical Face Mask
K203591 · FXX
Conod Medical Co., Limited
General Hospital · 206d
Cleared Jul 02, 2021
SyntrFuge System
K203800 · MUU
Syntr Health Technologies, Inc.
General & Plastic Surgery · 186d
Cleared Jul 02, 2021
Estar-Z
K210097 · EIH
Osstem Implant Co., Ltd.
Dental · 169d
Cleared Jul 02, 2021
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
K210127 · LKM
Beckman Coulter, Inc.
Hematology · 164d
Cleared Jul 02, 2021
RICOH MEG
K210199 · OLX
Ricoh Company, Ltd.
Neurology · 158d
Cleared Jul 02, 2021
Selethru(TM) NC PTCA Balloon Dilatation Catheter
K211393 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 58d
Cleared Jul 02, 2021
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3...
K211422 · FYA
Jiangsu Medplus Non-Woven...
General Hospital · 56d
Cleared Jul 01, 2021
Pulmogine Vibrating Mesh Nebulizer
K202171 · CAF
Hcmed Innovations Co., Ltd.
Anesthesiology · 332d
Cleared Jul 01, 2021
Cannula for Organ Perfusion
K203262 · KDN
Bridge TO Life, Ltd.
Gastroenterology & Urology · 238d
Cleared Jul 01, 2021
Avance Solo Negative Pressure Wound Therapy (NPWT) System
K203369 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 227d
Cleared Jul 01, 2021
GlidePath Retro Long-Term Hemodialysis Catheter
K203575 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 206d
Cleared Jul 01, 2021
MAZIC Claro CAD and MAZIC Claro Press
K203672 · EIH
Vericom Co., Ltd.
Dental · 197d
Cleared Jul 01, 2021
Bravo G4 Chamber Autoclave
K210326 · FLE
Scican , Ltd.
General Hospital · 147d
Cleared Jul 01, 2021
MAGNETOM Free.Max
K210611 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Jul 01, 2021
Snore Bandit
K210910 · LRK
Snorebandit, LLC
Dental · 94d
Cleared Jul 01, 2021
EZ-TRAXTM Persona Knee Containment Device
K211007 · KCT
K1 Medical, LLC
General Hospital · 90d
Cleared Jul 01, 2021
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K211337 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
K211411 · NRY
Penumbra, Inc.
Neurology · 56d
Cleared Jul 01, 2021
decimal Bolus
K211511 · MUJ
.Decimal, LLC
Radiology · 48d
Cleared Jul 01, 2021
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
K211782 · OWB
Controlrad, Inc.
Radiology · 22d
Cleared CT Jun 30, 2021
Pivot Breath Sensor
K201206 · CCJ
Carrot, Inc.
Toxicology · 422d