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
26113–26136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2018
Viz CTP
K180161 · LLZ
Viz. Ai, Inc.
Radiology · 91d
Cleared Apr 20, 2018
JO H2O Flavored Personal Lubricants
K180219 · NUC
United Consortium
Obstetrics & Gynecology · 85d
Cleared Apr 20, 2018
Geri Embryo Incubator and Geri Dish
K180304 · MQG
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 77d
Cleared Apr 20, 2018
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
K180322 · LPL
Visco Vision, Inc.
Ophthalmic · 74d
Cleared Apr 20, 2018
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
K180451 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 59d
Cleared Apr 20, 2018
PICO Single Use Negative Pressure Wound Therapy System
K180618 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 42d
Cleared Apr 20, 2018
World Knee System
K180750 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 29d
Cleared Apr 20, 2018
SafetyFix EasyOut System
K180753 · HWC
Safetyfix Medical Technologies, Inc.
Orthopedic · 29d
Cleared Apr 20, 2018
Televere Podiatry X-Ray System HF
K180765 · KPR
Televere Systems, Inc.
Radiology · 28d
Cleared Apr 20, 2018
Aria
K180782 · KGI
GE Medical Systems Ultrasound &...
Radiology · 25d
Cleared Apr 19, 2018
encevis
K171720 · OMB
Ait Austrian Institute of Technology...
Neurology · 311d
Cleared Apr 19, 2018
Isolette 8000 plus
K172154 · FMZ
Draeger Medical Sytems, Inc.
General Hospital · 276d
Cleared Apr 19, 2018
Zenith Flex System
K172167 · NRY
Inneuroco, Inc.
Neurology · 275d
Cleared Apr 19, 2018
SuperSlyde Personal Lubricant
K172306 · NUC
Icm Pharma Pte, Ltd.
Obstetrics & Gynecology · 262d
Cleared Apr 19, 2018
Panoramic Oxygen Mask (POM)
K172365 · CCK
Pom Medical, LLC
Anesthesiology · 258d
Cleared Apr 19, 2018
Synermed Opiate Enzyme Immunoassay
K172416 · DJG
Infrared Laboratory Systems, LLC (Dba...
Toxicology · 252d
Cleared Apr 19, 2018
AViTA Radar Thermo NT16 Series IR Thermometer
K172427 · FLL
Avita Corporation
General Hospital · 252d
Cleared Apr 19, 2018
iSchemaView RAPID
K172477 · LLZ
Ischemaview, Inc.
Radiology · 246d
Cleared Apr 19, 2018
TENS device-EmeTerm, CinvStop
K172478 · GZJ
Wat Medical Technology (Ningbo) Co.,...
Neurology · 246d
Cleared Apr 19, 2018
Balloon Catheter and Balloon Ureteral Dilator Set
K172588 · EZN
Cook Incorporated
Gastroenterology & Urology · 233d
Cleared Apr 19, 2018
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical...
K172598 · MLY
Itw Contamination Control Electronics
Physical Medicine · 233d
Cleared Apr 19, 2018
XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck...
K172887 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 210d
Cleared Apr 19, 2018
EV-804 OTC Pain Relief TENS
K172919 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 206d
Cleared Apr 19, 2018
MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments
K173472 · PQC
Medacta International S.A.
Orthopedic · 161d