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

Filters: Cleared only ×
175,820 results
16201–16224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · FLL
Longnan Renzhong Medical Equipment...
General Hospital · 239d
Cleared Sep 15, 2021
TrueCare Biomedix Tamper Evident Cap
K210818 · FMF
Us Infusion Inc. D/B/A Truecare...
General Hospital · 181d
Cleared Sep 15, 2021
HTx Disposable Hysteroscope System
K211227 · HIH
Acuvu, Inc.
Obstetrics & Gynecology · 145d
Cleared Sep 15, 2021
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
K211276 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Sep 15, 2021
Disposable Nitrile Gloves
K212009 · LZA
Jiangsu Shenglijie Safety Products...
General Hospital · 79d
Cleared Sep 15, 2021
mi-eye 3 needlescope with cannula, mi-tablet 3
K212556 · HRX
Trice Medical, Inc.
Orthopedic · 33d
Cleared Sep 15, 2021
BeamSite
K212606 · IYE
Doseoptics, LLC
Radiology · 29d
Cleared Sep 15, 2021
GLOBAL UNITE™ Platform Shoulder System
K212710 · PHX
Depuy Ireland UC
Orthopedic · 20d
Cleared Sep 14, 2021
LIAISON Ferritin
K193650 · DBF
DiaSorin, Inc.
Immunology · 624d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · LON
bioMerieux, Inc.
Microbiology · 389d
Cleared Sep 14, 2021
Wilson Tech Disposable Medical Face Mask
K210184 · FXX
Wilson Tech (International) Limited
General Hospital · 232d
Cleared Sep 14, 2021
End Cap
K210461 · MSD
Medical Components Inc (Medcomp)
Gastroenterology & Urology · 210d
Cleared Sep 14, 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth...
K210586 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 200d
Cleared Sep 14, 2021
Compressible Limb and Circulation Therapy System, Model POWER-Q2300
K211283 · IRP
Wonjin Mulsan Co., Ltd.
Physical Medicine · 140d
Cleared Sep 14, 2021
ANNE One
K211305 · DRG
Sibel, Inc.
Cardiovascular · 138d
Cleared Sep 14, 2021
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K211389 · OBP
Magstim Company, Ltd.
Neurology · 132d
Cleared Sep 14, 2021
Nitta M&T Safety Box
K211464 · MMK
Nitta M&T (Thailand) Co., Ltd.
General Hospital · 126d
Cleared Sep 14, 2021
Kleiner KG2 System
K211474 · MAX
BAAT Medical Products B.V.
Orthopedic · 125d
Cleared Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
K211494 · DRF
Boston Scientific Corporation
Cardiovascular · 124d
Cleared Sep 14, 2021
Rotarex Atherectomy System
K211738 · MCW
C.R. Bard, Inc.
Cardiovascular · 99d
Cleared Sep 14, 2021
PHOENIX
K212291 · IZL
Sedecal., Sa.
Radiology · 54d
Cleared Sep 14, 2021
Viveve System, Viveve 2.0 System
K212678 · GEI
Viveve Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 13, 2021
EDEN Peek Cage
K201793 · ODP
Jmt Co., Ltd.
Orthopedic · 440d
Cleared Sep 13, 2021
EliA Rib-P
K202540 · MQA
Phadia AB
Immunology · 376d