Search FDA 510(k) Database

6,442 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: Cleared only ×
174,061 results
8185–8208 of 174,061
Cleared Sep 01, 2023
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
K223674 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 268d
Cleared Sep 01, 2023
FaceHeart Vitals Software Development Kit (FH vitals SDK)
K223622 · QME
Faceheart Corp.
Cardiovascular · 270d
Cleared Sep 01, 2023
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
K222988 · ODP
Ht Medical D.B.A. Xenix Medical
Orthopedic · 338d
Cleared Sep 01, 2023
MS-39
K221601 · OBO
C.S.O. S.R.L.
Ophthalmic · 456d
Cleared Sep 01, 2023
Hemostatic Dressing
K213413 · QSY
Jiangsu Newvalue Medical Products...
General & Plastic Surgery · 682d
Cleared Sep 01, 2023
Brain Anesthesia Response Monitor (Bar Monitor)
K213273 · OLW
Cortical Dynamics , Ltd.
Anesthesiology · 701d
Cleared Aug 31, 2023
Powder Free Nitrile Examination Gloves (Black)
K232353 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 24d
Cleared Aug 31, 2023
RAYSCAN a-Expert3D
K232287 · OAS
Ray Co., Ltd.
Radiology · 30d
Cleared Aug 31, 2023
BioSieve™ Marijuana Test Panel 50
K231978 · NFW
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 59d
Cleared Aug 31, 2023
OSPREY Closed IV Catheter System (OspreyV2)
K231626 · FOZ
Skydance Vascular, Inc.
General Hospital · 90d
Cleared Aug 31, 2023
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
K231616 · KTL
Zeus Scientific
Immunology · 90d
Cleared Aug 31, 2023
HOLO Portal™ Surgical Guidance System
K231611 · SBF
Surgalign Spine Technologies
Orthopedic · 90d
Cleared Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution...
K231433 · NGZ
Thermo Fisher Scientific
Microbiology · 106d
Cleared Aug 31, 2023
Ancora-SB
K231323 · FDA
Aspero Medical, Inc.
Gastroenterology & Urology · 115d
Cleared Aug 31, 2023
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use...
K230578 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 183d
Cleared Aug 31, 2023
EL27-Compact
K230488 · FFK
Walz Elektronik GmbH
Gastroenterology & Urology · 189d
Cleared Aug 31, 2023
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for...
K223597 · QAZ
23AndMe, Inc.
Pathology · 272d
Cleared Aug 31, 2023
Little Wave Arc
K223533 · LBE
Ki Mobility, LLC
Physical Medicine · 281d
Cleared Aug 31, 2023
Little Wave Clik, Rogue XP, Little Wave XP, Spark
K223527 · IOR
Ki Mobility, LLC
Physical Medicine · 281d
Cleared Aug 31, 2023
BD Kiestra IdentifA
K222563 · QQV
Becton, Dickinson and Company
Microbiology · 372d
Cleared Aug 31, 2023
Q21
K221959 · GWQ
Neurofield, Inc.
Neurology · 422d
Cleared Aug 31, 2023
MedicloseTM System
K213271 · OCW
Health Value Creation B.V., Trading...
General & Plastic Surgery · 700d
Cleared Aug 30, 2023
AC3™ Series IABP
K232343 · DSP
Arrow International, LLC
Cardiovascular · 26d
Cleared Aug 30, 2023
StealthFix Intraosseous Fixation System
K232324 · JDR
Medartis, Inc.
Orthopedic · 27d