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

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175,820 results
14425–14448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2022
CARESCAPE B650, E-musb
K213181 · MHX
GE Healthcare Finland Oy
Cardiovascular · 196d
Cleared Apr 13, 2022
Carescape B850, E-musb
K213336 · MHX
GE Healthcare Finland Oy
Cardiovascular · 189d
Cleared Apr 13, 2022
CARESCAPE B450, E-musb
K213363 · MHX
GE Healthcare Finland Oy
Cardiovascular · 183d
Cleared Apr 13, 2022
Neodent Implant System-Helix NGM Compact Surgical Kit Cases
K214051 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 107d
Cleared Apr 13, 2022
Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip...
K220373 · LZA
Summit Glove, Inc.
General Hospital · 63d
Cleared Apr 13, 2022
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips,...
K220375 · LZA
Summit Glove, Inc.
General Hospital · 63d
Cleared Apr 13, 2022
OpenSensorX Series
K220556 · MUH
Dentimax, Inc.
Radiology · 44d
Cleared Apr 13, 2022
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773 · MAV
Medtronic Vascular
Cardiovascular · 28d
Cleared Apr 12, 2022
Ti3Z Lumbar Interbody System
K212811 · MAX
Zavation Medical Products, LLC
Orthopedic · 221d
Cleared Apr 12, 2022
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101,...
K213234 · MHX
Ge Medical Systems Information...
Cardiovascular · 194d
Cleared Apr 12, 2022
Anprolene SteriTest RRBI
K213296 · FRC
Andersen Sterilizers, Inc.
General Hospital · 193d
Cleared Apr 12, 2022
EMBOLD Fibered Detachable Coil System
K213398 · KRD
Boston Scientific Corporation
Cardiovascular · 176d
Cleared Apr 12, 2022
CARESCAPE CO2 Microstream parameter
K213518 · CCK
Covidien, LLC
Anesthesiology · 160d
Cleared Apr 12, 2022
Finexel
K213557 · GEX
Snj Co., Ltd.
General & Plastic Surgery · 155d
Cleared Apr 12, 2022
ThermPix Thermovisual Camera
K213650 · LHQ
Usa Therm, Inc.
Radiology · 144d
Cleared Apr 12, 2022
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K214010 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 111d
Cleared Apr 12, 2022
PROWLER SELECT LP ES Microcatheter
K214025 · KRA
Medos International SARL
Neurology · 111d
Cleared Apr 12, 2022
ClearPoint Array System (version 1.1)
K214040 · HAW
ClearPoint Neuro, Inc.
Neurology · 110d
Cleared Apr 12, 2022
Safety Blood Collection / Infusion Set (with/without needle holder), Blood...
K214075 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 106d
Cleared Apr 12, 2022
Disposable Surgical Gown
K214088 · FYA
Weihai Hongyu Nonwoven Fabric...
General Hospital · 105d
Cleared Apr 12, 2022
Audion ET dilation system
K220027 · PNZ
Entellus Medical, Inc.
Ear, Nose, Throat · 97d
Cleared Apr 12, 2022
LED Therapy Device (Planar LED/Planar LED mini)
K220103 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Apr 12, 2022
Amis K Long
K220405 · LZO
Medacta International S.A.
Orthopedic · 57d
Cleared Apr 11, 2022
Micro Catheter and Guidewire System
K212719 · KRA
Suzhou Hengrui Hongyuan Medical Co.,...
Cardiovascular · 227d