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
24625–24648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2018
Accipiolx
K182177 · QAS
Maxq-Al , Ltd.
Radiology · 77d
Cleared Oct 26, 2018
MAGNETOM Aera
K182299 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Oct 26, 2018
Hair Laser Headband
K182501 · OAP
Pulsaderm, LLC
General & Plastic Surgery · 44d
Cleared Oct 26, 2018
A6 OTC Pain Relief TENS
K182753 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Oct 26, 2018
V2 OTC Pain Relief TENS
K182767 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Oct 25, 2018
Swaive Thermometer SWT1A
K170723 · FLL
E-Care Technology Co., Ltd.
General Hospital · 595d
Cleared Oct 25, 2018
Endocular Viewing Lenses and Silicone Ring
K173944 · HJK
Phakos
Ophthalmic · 303d
Cleared Oct 25, 2018
SpeediCath Standard
K180258 · GBM
Coloplast
Gastroenterology & Urology · 268d
Cleared Oct 25, 2018
SLENDERTONE CoreFit Abs 8, Type 734
K180688 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 224d
Cleared Oct 25, 2018
CONVIVO
K181116 · GWG
Carl Zeiss Meditec, AG
General & Plastic Surgery · 181d
Cleared CT Oct 25, 2018
Solitare Platinum Revascularization Device
K181186 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 175d
Cleared Oct 25, 2018
074 Zenith Flex System
K181354 · NRY
Inneuroco, Inc.
Neurology · 156d
Cleared Oct 25, 2018
Hybrid3D
K181468 · KPS
Hermes Medical Solutions AB
Radiology · 143d
Cleared Oct 25, 2018
Vivid E80, Vivid E90, Vivid E95
K181685 · IYN
GE Medical Systems Ultrasound and...
Radiology · 121d
Cleared Oct 25, 2018
Codman Certas Plus Electronic Tool Kit
K181902 · JXG
Integra Lifesciences Corp.
Neurology · 101d
Cleared Oct 25, 2018
DyeVert PLUS EZ Contrast Reduction System
K181936 · DXT
Osprey Medical, Inc.
Cardiovascular · 98d
Cleared Oct 25, 2018
Persona Revision Knee System
K181947 · JWH
Zimmer, Inc.
Orthopedic · 97d
Cleared Oct 25, 2018
SMV Scientific K-Wire and Pins
K182171 · JDW
Summit Medventures
Orthopedic · 76d
Cleared Oct 25, 2018
PeekMed
K182464 · LLZ
Peek Health, S.A.
Radiology · 45d
Cleared Oct 25, 2018
External upper limb tremor stimulator
K182706 · QBC
Cala Health, Inc.
Neurology · 28d
Cleared Oct 24, 2018
Monarch Airway Clearance System
K173603 · BYI
Hill-Rom Holdings, Inc.
Anesthesiology · 337d
Cleared Oct 24, 2018
Certus 140 2.45GHz Ablation System
K173756 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 317d
Cleared Oct 24, 2018
VAMP Optima closed blood sampling system
K180275 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Oct 24, 2018
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™...
K180302 · MQF
Cook Incorporated
Obstetrics & Gynecology · 264d