Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
35881–35904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2015
12SL ECG ANALYSIS PROGRAM
K141963 · MHX
Ge Medical Systems Information...
Cardiovascular · 202d
Cleared Feb 05, 2015
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE,...
K141982 · LZC
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 199d
Cleared Feb 05, 2015
CO2 monitoring line with and without in-line filter
K143150 · CCK
Besmed Health Business Corp
Anesthesiology · 94d
Cleared Feb 05, 2015
SonicFill 2
K143209 · EBF
Sybron Dental Specialties
Dental · 87d
Cleared Feb 05, 2015
Acumed Small Bone IM Nail System
K143276 · HSB
Acumed, LLC
Orthopedic · 83d
Cleared Feb 04, 2015
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
K140828 · LLZ
Brainreader Aps
Radiology · 309d
Cleared Feb 04, 2015
DMRC Light Cure Orthodontic Adhesive System
K142880 · DYH
Daville Materials, LLC
Dental · 125d
Cleared Feb 04, 2015
Digital Diagnostic X-ray System (GC80)
K143029 · KPR
Samsung Electronics Co., Ltd.
Radiology · 106d
Cleared Feb 04, 2015
ACL SMART System
K143172 · MAI
Smith & Nephew, Inc.
Orthopedic · 92d
Cleared Feb 04, 2015
SIGNA Creator, SIGNA Explorer
K143251 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 84d
Cleared Feb 04, 2015
Extremity Medical Calcaneal Osteotomy Device
K143402 · HWC
Extremity Medical, LLC
Orthopedic · 68d
Cleared Feb 04, 2015
Laparoscopic Handles with peek Insulation
K150127 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 15d
Cleared Feb 03, 2015
BWMINI EEG, BWMINIHST, BWMINI PSG
K131335 · GWQ
Neurovirtual USA, Inc.
Neurology · 635d
Cleared Feb 03, 2015
ENGSTROM CARESTATION, ENGSTROM PRO
K140575 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 334d
Cleared Feb 03, 2015
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
K141666 · MQF
Fertiligent, Ltd.
Obstetrics & Gynecology · 225d
Cleared Feb 03, 2015
ECHOSTAR COMFORT 1.5T MRI
K141945 · LNH
Alltech Medical Systems America, Inc.
Radiology · 201d
Cleared Feb 03, 2015
Ebony PTA 0.014 RX Peripheral Dilatation Catheter
K142459 · LIT
Natec Medical , Ltd.
Cardiovascular · 154d
Cleared Feb 03, 2015
ThinkMed Intermittent Catheter with/without Hydrophilic Coating
K142767 · GBM
Thinkmed Medical Technology Co., Ltd.
Gastroenterology & Urology · 131d
Cleared Feb 03, 2015
TCS Blend
K142894 · EBI
Thermoplastic Comfort Systems, Inc.
Dental · 123d
Cleared Feb 03, 2015
MIS Z-Pedicle Screw System
K143200 · NKB
Z-Medical GmbH & Co. KG
Orthopedic · 89d
Cleared Feb 03, 2015
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
K143362 · OMP
Devon Medical Products
General & Plastic Surgery · 71d
Cleared Feb 03, 2015
Infusion Aspiration Catheter System
K143563 · QEW
Inari Medical, Inc.
Cardiovascular · 49d
Cleared Feb 02, 2015
PREMIUM, SHELTA Implant Systems
K142242 · DZE
Sweden & Martina S.P.A.
Dental · 173d
Cleared Jan 30, 2015
MULTIPULSE TM+1470
K133891 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 406d