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
6889–6912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2024
Hushd Pro Avera
K232025 · LRK
Good Sleep CO Pte , Ltd.
Dental · 307d
Cleared May 08, 2024
Tricera Arthroscopic System
K241008 · GEI
Relign Corporation, Subsidiary of...
Orthopedic · 26d
Cleared May 08, 2024
Legend X Applicator VO
K240999 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 27d
Cleared May 08, 2024
FLOW 90? Wand
K240964 · GEI
ArthroCare Corporation
General & Plastic Surgery · 29d
Cleared May 08, 2024
UltraClear Laser System (N/A)
K233803 · GEX
Acclaro Corporation
General & Plastic Surgery · 161d
Cleared May 08, 2024
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
K233581 · DHA
Ortho-Clinical Diagnostics
Chemistry · 183d
Cleared May 08, 2024
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K232649 · LPL
Pegavision Corporation
Ophthalmic · 251d
Cleared May 08, 2024
F&P myAirvo 3
K222292 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 649d
Cleared May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K240954 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared May 07, 2024
LIFEPAK® ECG Cables
K240377 · DSA
Stryker Physio-Control
Cardiovascular · 90d
Cleared May 07, 2024
AEON Endoscopic Powered Stapler (Short/AEPH060)
K234039 · GAG
Lexington Medical, Inc.
General & Plastic Surgery · 138d
Cleared May 07, 2024
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
K234018 · NHA
Dentsply Sirona
Dental · 139d
Cleared May 07, 2024
ASSURE Wearable ECG
K233864 · MWJ
Kestra Medical Technologies, Inc.
Cardiovascular · 153d
Cleared May 07, 2024
Geneo X Elite
K233766 · PAY
Pollogen, Ltd.
General & Plastic Surgery · 165d
Cleared May 07, 2024
Medical HAL Lower Limb Type (HAL-ML)
K233695 · PHL
Cyberdyne, Inc.
Neurology · 172d
Cleared May 07, 2024
DeepContour (V1.0)
K232928 · QKB
Wisdom Technologies., Inc.
Radiology · 230d
Cleared May 07, 2024
HALO AP Dx
K232833 · PSY
Indica Labs, Inc.
Pathology · 237d
Cleared May 07, 2024
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
K232493 · MQG
Wuhan Huchuang Union Technology Co.,...
Obstetrics & Gynecology · 264d
Cleared May 07, 2024
KARL STORZ Monopolar Resectoscopes with HF Cable
K232486 · FJL
Karl Storz SE & CO. KG
Gastroenterology & Urology · 265d
Cleared May 07, 2024
Eve Patient Positioner System
K231612 · JAI
Leo Cancer Care
Radiology · 340d
Cleared May 06, 2024
Salvo® Spine System
K240685 · NKB
Spine Wave, Inc.
Orthopedic · 55d
Cleared May 06, 2024
JAZZ Spinal System
K240392 · NKB
Implanet
Orthopedic · 88d
Cleared May 06, 2024
Solar Compact (G4-1)
K240007 · FFX
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 125d
Cleared May 06, 2024
ViSiGi LUX (5332)
K234033 · KNT
Boehringer Laboratories, LLC
Gastroenterology & Urology · 138d