FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
13105–13128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2022
EpilME
K213261 · GEX
Neauvia North America
General & Plastic Surgery · 245d
Cleared Jun 02, 2022
Q2 IV Administration Sets
K213588 · FPA
Quest Medical, Inc.
General Hospital · 202d
Cleared Jun 02, 2022
Leaseir MHR Xcell
K214049 · GEX
Leaseir Technologies, Slu
General & Plastic Surgery · 157d
Cleared Jun 02, 2022
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K220008 · NCX
Zoll Circulation, Inc.
Neurology · 149d
Cleared Jun 02, 2022
Rayvolve
K220164 · QBS
Azmed Sas
Radiology · 133d
Cleared Jun 02, 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile...
K220541 · LZA
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 02, 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile...
K220547 · LZA
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 02, 2022
Zavation eZspand Interbody System
K220581 · MAX
Zavation Medical Products, LLC
Orthopedic · 93d
Cleared Jun 02, 2022
Boss Crossing Support Catheter
K220632 · DQY
Marvao Medical Devices, Ltd.
Cardiovascular · 90d
Cleared Jun 02, 2022
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
K220751 · NHA
Institut Straumann AG
Dental · 79d
Cleared Jun 02, 2022
M6-C Artificial Cervical Disc Instruments AS
K220861 · QLQ
Spinal Kinetics, LLC
Orthopedic · 70d
Cleared Jun 02, 2022
IPL Hair Removal
K220927 · OHT
Shenzhen Qiaochengli Technology Co.,...
General & Plastic Surgery · 63d
Cleared Jun 02, 2022
Restoris Multi-Compartmental Knee System
K220930 · HSX
Mako Surgical Corp.
Orthopedic · 63d
Cleared Jun 01, 2022
4CIS Chiron Spinal Fixation System
K203233 · NKB
Solco Biomedical Co., Ltd.
Orthopedic · 576d
Cleared Jun 01, 2022
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
K210107 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 502d
Cleared Jun 01, 2022
freeflex+ Transfer Adapter
K212445 · LHI
Fresenius Kabi AG
General Hospital · 300d
Cleared Jun 01, 2022
DeltaFil, DeltaFil Conditioner
K213201 · EMA
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 245d
Cleared Jun 01, 2022
Purgo
K213753 · FRA
Aeroclean Technologies, LLC
General Hospital · 183d
Cleared Jun 01, 2022
AneuGuide
K213838 · PZO
ArteryFlow Technology Co., Ltd.
Neurology · 174d
Cleared Jun 01, 2022
BeneVision Central Monitoring System
K220058 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 146d
Cleared Jun 01, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with...
K220488 · LZA
Anhui Zhong Lian Latex Gloves...
General Hospital · 99d
Cleared Jun 01, 2022
TriMed Ripcord Device
K220650 · HTN
TriMed, Inc.
Orthopedic · 86d
Cleared Jun 01, 2022
CoreLink Navigation Instruments
K220973 · OLO
Corelink, LLC
Orthopedic · 58d
Cleared Jun 01, 2022
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
K221002 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 58d