FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
5329–5352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2024
PowerCube+ Series (PowerCube Body+)
K240706 · JEH
Ganshorn Medizin Electronic GmbH
Anesthesiology · 270d
Cleared Dec 08, 2024
HomeSleepTest (HST, HST REM+)
K240700 · OLV
Somnomedics GmbH
Neurology · 269d
Cleared Dec 06, 2024
SmartSiteTM Vented Vial Access Device
K243486 · LHI
Yukon Medical, LLC
General Hospital · 28d
Cleared Dec 06, 2024
AnyPlus Navigated Instruments System
K243073 · OLO
GS Medical Co., Ltd.
Orthopedic · 70d
Cleared Dec 06, 2024
WallFlex Biliary PLUS RX Stent System
K242950 · FGE
Boston Scientific
Gastroenterology & Urology · 74d
Cleared Dec 06, 2024
PTFE Guidewire
K242824 · DQX
Lake Region Medical
Cardiovascular · 79d
Cleared Dec 06, 2024
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro,...
K242710 · OHT
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 88d
Cleared Dec 06, 2024
NanoKnife Generator (H78720300301US0)
K242687 · OAB
AngioDynamics, Inc.
Gastroenterology & Urology · 91d
Cleared Dec 06, 2024
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
K242645 · NUC
Project Chemistry, Inc.
Obstetrics & Gynecology · 94d
Cleared Dec 06, 2024
SyMRI
K242524 · LNH
Syntheticmr AB (Publ.)
Radiology · 105d
Cleared Dec 06, 2024
RED
K242304 · KLA
Neuraxis, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 06, 2024
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
K241989 · LLZ
Cercare Medical A/S
Radiology · 151d
Cleared Dec 06, 2024
PeritX™ 1L Drainage Kit (90-1010)
K241946 · PNG
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 06, 2024
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
K241923 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 158d
Cleared Dec 06, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 161d
Cleared Dec 06, 2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
K241580 · QQX
Abbott Molecular
Microbiology · 186d
Cleared Dec 06, 2024
MC2 Portable X-ray System
K241567 · OWB
Oxos Medical
Radiology · 189d
Cleared Dec 06, 2024
DrAid™ for Liver Segmentation
K241543 · QIH
Vinbrain Joint Stock Company
Radiology · 189d
Cleared Dec 06, 2024
ACTIFY™ Unicondylar Knee System
K241260 · HSX
Globus Medical, Inc.
Orthopedic · 214d
Cleared Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
K241213 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 220d
Cleared Dec 06, 2024
DZ-Tabone Intervertebral Body Fusion Device
K241073 · MAX
Shenzhen Dazhou Medical Technology...
Orthopedic · 231d
Cleared Dec 06, 2024
87 NeuGlide Catheter
K240971 · QJP
Piraeus Medical
Neurology · 241d
Cleared Dec 06, 2024
PeekMed web
K240926 · LLZ
Peek Health, S.A.
Radiology · 246d
Cleared Dec 06, 2024
Oxygen Concentrator (ZY-10AB/115)
K240840 · CAW
Foshan Care Medical Technology Co., Ltd.
Anesthesiology · 254d