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
4657–4680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2025
Ventripoint Medical System Plus (VMS+) 4.0
K241222 · QIH
Ventripoint Diagnostics , Ltd.
Radiology · 301d
Cleared Feb 25, 2025
JLK-AILink
K250348 · LLZ
JLK, Inc.
Radiology · 19d
Cleared Feb 25, 2025
WasherCap™ Fixation System
K250238 · MBI
Abanza Tecnomed S.L
Orthopedic · 29d
Cleared Feb 25, 2025
BruxZir® Esthetic NOW
K250223 · EIH
Prismatik Dentalcraft, Inc.
Dental · 29d
Cleared Feb 25, 2025
3DXR
K243446 · OWB
GE Medical Systems SCS
Radiology · 111d
Cleared Feb 25, 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 132d
Cleared Feb 25, 2025
Loss of Pulse Detection
K242967 · SDY
Fitbit
Cardiovascular · 152d
Cleared Feb 25, 2025
ART-Plan+ (v.3.0.0)
K242822 · MUJ
Therapanacea Sas
Radiology · 160d
Cleared Feb 25, 2025
EMS (FlexPulse, MagnaCore, Magnetika)
K241601 · NGX
Cpmt Laser (Canadian Pioneer Medical...
Physical Medicine · 266d
Cleared Feb 25, 2025
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
K233963 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 438d
Cleared Feb 24, 2025
ExamVue Apex
K244010 · MQB
Jpi Healthcare Co, Ltd.
Radiology · 60d
Cleared Feb 24, 2025
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use...
K243959 · LZC
Lingshi Hongruida Health Protection...
General Hospital · 63d
Cleared Feb 24, 2025
Control-IQ+ technology
K243823 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 74d
Cleared Feb 24, 2025
APRO 70 Swift Catheter and Alembic Aspiration Tubing
K243287 · NRY
Alembic, LLC
Neurology · 129d
Cleared Feb 24, 2025
Ulthera® System
K243035 · OHV
Ulthera, Inc.
General & Plastic Surgery · 150d
Cleared Feb 24, 2025
OncoStudio (OS-01)
K242994 · QKB
Oncosoft. Co., Ltd.
Radiology · 151d
Cleared Feb 24, 2025
SD Implant System
K241703 · DZE
Arum Dentistry Co., Ltd.
Dental · 256d
Cleared Feb 24, 2025
Sterilization Package/Reel
K241565 · FRG
Anqing Clean Dental Instrument...
General Hospital · 269d
Cleared Feb 21, 2025
Xpert® FII & FV
K250218 · NPR
Cepheid
Hematology · 28d
Cleared Feb 21, 2025
Powered Mobility Scooter
K250027 · INI
Intradin (Shanghai) Machinery Co., Ltd.
Physical Medicine · 46d
Cleared Feb 21, 2025
TEMP MASTER, PMMA-based dental resin
K243951 · EBG
Taiwan Dental Materials Co., Ltd.
Dental · 60d
Cleared Feb 21, 2025
VITA YZ Multi Translucent
K243940 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 63d
Cleared Feb 21, 2025
Primus Spinal Fixation System
K243916 · NKB
Spinal Elements, Inc.
Orthopedic · 63d
Cleared Feb 21, 2025
Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra...
K243640 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 88d