Search FDA 510(k) Devices

5,418 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
889–912 of 3,347
Cleared Sep 29, 2023
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible...
K231702 · FAJ
OTU Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Sep 29, 2023
Intraosseous Fusion Device System
K231649 · HWC
Auxano Medical, LLC
Orthopedic · 115d
Cleared Sep 29, 2023
BeShape One™ Device
K231628 · OHV
Beshape Technologies , Ltd.
General & Plastic Surgery · 116d
Cleared Sep 29, 2023
REGER Nebulizer Irrigation Cannula
K231622 · GCJ
Reger Medizintechnik, GmbH
General & Plastic Surgery · 119d
Cleared Sep 29, 2023
TriALTIS Navigation Enabled Instruments
K231527 · OLO
Medos International S?rl
Orthopedic · 126d
Cleared Sep 29, 2023
Chemotherapy Gloves
K230847 · LZA
3A Glove Sdn. Bhd.
General Hospital · 185d
Cleared Sep 29, 2023
TriLEAP Plating System
K230591 · HRS
Crossroads Extremity Systems
Orthopedic · 210d
Cleared Sep 29, 2023
Terran NM-101
K230187 · LNH
Terran Biosciences, Inc.
Radiology · 249d
Cleared Sep 29, 2023
HipCheck
K230045 · QIH
Stryker Corp.
Radiology · 266d
Cleared Sep 29, 2023
Boppli Infant Blood Pressure Monitor
K223873 · DXN
Pyrames, Inc.
Cardiovascular · 280d
Cleared Sep 29, 2023
Miris Human Milk Analyzer (HMA)
K223085 · QEI
Miris AB
Chemistry · 364d
Cleared Sep 29, 2023
Stat Profile Prime Plus Analyzer System
K221900 · CHL
Nova Biomedical Corporation
Chemistry · 456d
Cleared Sep 29, 2023
Antibacterial bandage
K221570 · FRO
Allmed Medical Products Co., Ltd.
General & Plastic Surgery · 486d
Cleared Sep 29, 2023
AnemoCheck Home
K221508 · KHG
Sanguina, Inc.
Hematology · 493d
Cleared Sep 29, 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2...
K221359 · JPA
Instrumentation Laboratory CO
Hematology · 506d
Cleared Sep 29, 2023
StarFormer, TightWave
K221274 · IPF
Fotona D.O.O.
Physical Medicine · 515d
Cleared Sep 29, 2023
UltraFlo-R Push Button Blood Collection Set
K220458 · JKA
Innovative Medical Technologies, Inc.
General Hospital · 589d
Cleared Sep 29, 2023
Aptiva CTD Essential Reagent
K213403 · LLL
Inova Diagnostics, Inc.
Immunology · 711d
Cleared Sep 29, 2023
DYNEX SmartPLEX MMRV IgG Assay Kit
K212769 · OPL
Dynex Technologies, Inc.
Microbiology · 759d
Not Cleared Sep 29, 2023
Procise ADL
DEN220023 · QYD
Procisedx, Inc.
Toxicology · 543d
Not Cleared Sep 29, 2023
Procise IFX
DEN210056 · QXT
Procisedx, Inc.
Toxicology · 660d
Not Cleared Sep 29, 2023
Invitae Common Hereditary Cancers Panel
DEN210011 · QVU
Invitae Corporation
Medical Genetics · 914d
Cleared Sep 28, 2023
BeautiLink SA
K233161 · EMA
Shofu Dental Corporation
Dental · 1d
Cleared Sep 28, 2023
Low Ejection Fraction AI-ECG Algorithm
K232699 · QYE
Anumana, Inc.
Cardiovascular · 23d