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
13681–13704 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2022
Air Compression Leg Massager (model: FE-7204B)
K211850 · IRP
Xiamen Healthpal Electronic Co.,Ltd
Physical Medicine · 261d
Cleared Mar 03, 2022
MyndMove 2.0
K212149 · GZI
Myndtec, Inc.
Physical Medicine · 237d
Cleared Mar 03, 2022
Osteon Precision Milled Suprastructure
K212676 · NHA
Implant Solutions Pty Ltd (Osteon...
Dental · 191d
Cleared Mar 03, 2022
nordicDSC
K212720 · LLZ
Nordicneurolab AS
Radiology · 188d
Cleared Mar 03, 2022
easy Claire
K213285 · OHS
Y & J Bio Co., Ltd.
General & Plastic Surgery · 153d
Cleared Mar 03, 2022
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed...
K213516 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 120d
Cleared Mar 03, 2022
Astroglide Sensual Strawberry Personal Lubricant
K213671 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 101d
Cleared Mar 03, 2022
IV Administration Set
K213778 · FPA
B.Braun Medical, Inc.
General Hospital · 90d
Cleared Mar 03, 2022
TENS & EMS Device
K213835 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 84d
Cleared Mar 03, 2022
MR Elastography
K220018 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Mar 03, 2022
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
K220379 · KWQ
Medynus, Inc.
Orthopedic · 21d
Cleared Mar 02, 2022
Bio Fluff System
K201861 · KPL
Gnali Bocia S.R.L.
Gastroenterology & Urology · 604d
Cleared Mar 02, 2022
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number:...
K203376 · FXX
Medtecs (Taiwan) Corp.
General Hospital · 470d
Cleared Mar 02, 2022
Southern Implants Instrument Trays
K210923 · KCT
Southern Implants (Pty), Ltd.
General Hospital · 338d
Cleared Mar 02, 2022
Sugita AVM Microclips
K211183 · HCH
Mizuho America, Inc.
Neurology · 316d
Cleared Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
K212379 · DFH
Siemens Healthcare Diagnostics...
Immunology · 212d
Cleared Mar 02, 2022
Sterile Syringe with Fixed Safety Needle for Single Use
K212652 · MEG
Gemtier Medical (Shanghai), Inc.
General Hospital · 191d
Cleared Mar 02, 2022
Plus Medical Isolation Gown Level 3
K212698 · FYC
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 189d
Cleared Mar 02, 2022
ReNew Disposable Scissor Tips
K213127 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 156d
Cleared Mar 02, 2022
Plasma Edge resection and vaporization electrodes, Plasma Edge working...
K213135 · FAS
Chirurgie Innovation
Gastroenterology & Urology · 156d
Cleared Mar 02, 2022
NovaGuide 2 Intelligent Ultrasound
K213279 · IYN
Novasignal Corporation
Radiology · 152d
Cleared Mar 02, 2022
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance...
K213457 · FLE
Fort Defiance Industries, LLC
General Hospital · 126d
Cleared Mar 02, 2022
Giraffe Omnibed Carestation CS1
K213551 · FMT
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Mar 02, 2022
Giraffe Incubator Carestation CS1
K213553 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 114d