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
26881–26904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2018
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare...
K171971 · CJE
Lite-On Technology Corp. H.S.P.B.
Chemistry · 209d
Cleared Jan 25, 2018
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS...
K172116 · HRX
Stryker Corporation
Orthopedic · 196d
Cleared Jan 25, 2018
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
K173060 · CBK
Fisher and Paykel Healthcare Limited
Anesthesiology · 119d
Cleared Jan 25, 2018
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
K173062 · FXX
V&Q Manufacturing Corporation
General Hospital · 119d
Cleared Jan 25, 2018
CliniCloud Stethoscope
K173448 · DQD
Stethocloud Pty.Ltd (Clinicloud)
Cardiovascular · 80d
Cleared Jan 25, 2018
Arterys Oncology DL
K173542 · LLZ
Arterys, Inc.
Radiology · 70d
Cleared Jan 25, 2018
Gallant PTCA Dilatation Catheter
K173581 · LOX
Medinol, Ltd.
Cardiovascular · 66d
Cleared Jan 24, 2018
Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
K171528 · IYO
Avantsonic Technology Co., Ltd.
Radiology · 244d
Cleared Jan 24, 2018
Electrocardiograph
K171942 · DPS
Edan Instruments, Inc.
Cardiovascular · 210d
Cleared Jan 24, 2018
SUNTOUCH Dental Dressing
K173196 · OLR
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 114d
Cleared Jan 24, 2018
Cycler Drain Bag Set
K173363 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Jan 24, 2018
SeaSpine Cabo ACP (Anterior Cervical Plate) System
K173521 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 71d
Cleared Jan 24, 2018
Cybird LED Curing Light
K173876 · EBZ
Dxm Co., Ltd.
Dental · 34d
Cleared Jan 23, 2018
C2 CryoBalloon Ablation System
K163684 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 391d
Cleared Jan 23, 2018
ARROW Reverse Porous Glenoid
K171789 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 222d
Cleared Jan 23, 2018
TruAbutment DS
K172304 · NHA
Truabutment, Inc.
Dental · 176d
Cleared CT Jan 23, 2018
gammaCore-S
K173442 · PKR
Electrocore, LLC
Neurology · 78d
Cleared Jan 22, 2018
Kit Boxes and Kit Plates
K163600 · KCT
Nobel Biocare AB
General Hospital · 397d
Cleared Jan 22, 2018
FortiCore®
K171312 · MAX
Nanovis, LLC
Orthopedic · 263d
Cleared Jan 22, 2018
CONTEC™ Electrocardiograph
K171360 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 258d
Cleared Jan 22, 2018
3D APT
K172920 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Jan 22, 2018
CAMPYLOBACTER QUIK CHEK
K173217 · LQP
Techlab, Inc.
Microbiology · 111d
Cleared Jan 22, 2018
CAMPYLOBACTER CHEK
K173219 · LQP
Techlab, Inc.
Microbiology · 111d
Cleared Jan 22, 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm,...
K173235 · DQX
Scientia Vascular, LLC
Cardiovascular · 109d