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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13321–13344 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2022
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number...
K210148 · FYC
Flomak Tekstil Makine Muh. Mum. Taah....
General Hospital · 447d
Cleared Apr 13, 2022
BIOTEQ Drainage Catheter BT-PDS-series
K210419 · FGE
Bioteque Corporation
Gastroenterology & Urology · 426d
Cleared Apr 13, 2022
MCL 31 Dermablate System
K210634 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 406d
Cleared Apr 13, 2022
ZENEX Implant System
K211090 · DZE
Izenimplant Co., Ltd.
Dental · 366d
Cleared Apr 13, 2022
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible...
K212202 · FAJ
OTU Medical, Inc.
Gastroenterology & Urology · 273d
Cleared Apr 13, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument...
K212245 · OLO
Brainlab AG
Orthopedic · 268d
Cleared Apr 13, 2022
Sensuva Premium Silicone Personal Lubricant
K212260 · NUC
Valencia Naturals, Inc.
Obstetrics & Gynecology · 267d
Cleared Apr 13, 2022
Keffort (MC-100, MC-100A)
K213133 · KPI
Oriental Inspiration Limited
Gastroenterology & Urology · 198d
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