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
7177–7200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 06, 2024
Vertos mild Device Kit (MDK-0002)
K233800 · HRX
Vertos Medical, Inc.
Orthopedic · 159d
Cleared May 06, 2024
MIM – Dose Analysis
K232514 · LLZ
Mim Software, Inc.
Radiology · 262d
Cleared May 03, 2024
Vial2Bag Advanced® 20mm Admixture Device
K240940 · LHI
West Pharmaceutical Services, Inc.
General Hospital · 28d
Cleared May 03, 2024
Silk Voice (SMI-04)
K240919 · MIX
Sofregen Medical
Ear, Nose, Throat · 30d
Cleared May 03, 2024
Access Intrinsic Factor Ab
K240800 · LIG
Beckman Coulter, Inc.
Chemistry · 39d
Cleared May 03, 2024
CORUS Navigation Access System
K240625 · OLO
Providence Medical Technology, Inc.
Orthopedic · 58d
Cleared May 03, 2024
Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
K240297 · OAB
Us Medical Innovations, LLC
General & Plastic Surgery · 92d
Cleared May 03, 2024
Cypris eXact Suture Placement Device
K240185 · GEJ
Cypris Medical
General & Plastic Surgery · 101d
Cleared May 03, 2024
ProAM ALIF System
K240126 · OVD
Pro Surgical, Inc.
Orthopedic · 108d
Cleared May 03, 2024
Emily's Care Nourish Test System (Model 1)
K234088 · QEI
Lactation Lab, Inc.
Chemistry · 133d
Cleared May 03, 2024
Masimo Stork
K234021 · QYU
Masimo Corporation
Cardiovascular · 135d
Cleared May 03, 2024
ECHELON Synergy V10.0
K233687 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 168d
Cleared May 03, 2024
Sleeved IC 2 Family
K233524 · EZD
Hollister Incorporated
Gastroenterology & Urology · 184d