FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
14449–14472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
K212341 · DTZ
Qura S.R.L
Cardiovascular · 184d
Cleared Jan 28, 2022
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
K212533 · DZE
Institut Straumann AG
Dental · 170d
Cleared Jan 28, 2022
iHealth infrared Ear thermometer PT5
K212598 · FLL
Andon Health Co, Ltd.
General Hospital · 165d
Cleared Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
K212648 · JHX
Ortho-Clinical Diagnostics
Chemistry · 158d
Cleared Jan 28, 2022
SyntheCel Dura Repair
K212943 · GXQ
Synthes USA Products, LLC
Neurology · 135d
Cleared Jan 28, 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Jan 28, 2022
STEP-1 PumEtch
K213093 · KLE
Rounding Third, LLC
Dental · 126d
Cleared Jan 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K213142 · LZA
Shen Wei (Usa), Inc.
General Hospital · 123d
Cleared Jan 28, 2022
ShinEvac Smoke Evacuation Pencil
K213317 · GEI
Shining World Health Care Co., Ltd.
General & Plastic Surgery · 116d
Cleared Jan 28, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With...
K213325 · LZC
Anhui Xinyisheng Medical Technology...
General Hospital · 115d
Cleared Jan 28, 2022
X-CUBE i8, X-CUBE i9
K213523 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 86d
Cleared Jan 28, 2022
QuikPass Catheter
K214106 · DQY
Traverse Vascular, Inc.
Cardiovascular · 30d
Cleared Jan 27, 2022
Omnipod 5 ACE Pump (Pod)
K203768 · QFG
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Omnipod 5 SmartBolus Calculator
K203772 · QRX
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
SmartAdjust technology
K203774 · QJI
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models),...
K210360 · GWO
Osteonic Co., Ltd.
Neurology · 353d
Cleared Jan 27, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K211210 · FMF
Azur Medical Company, Inc.
General Hospital · 279d
Cleared Jan 27, 2022
Intermittent Catheter (Not Finalized)
K211436 · GBM
Hollister Incorporated
Gastroenterology & Urology · 262d
Cleared Jan 27, 2022
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek...
K211589 · DPW
Remington Medical, Inc.
Cardiovascular · 248d
Cleared Jan 27, 2022
9Line
K211941 · DSA
Energetic Designs, Inc.
Cardiovascular · 218d
Cleared Jan 27, 2022
RA-T59 Wrist blood pressure monitor
K212312 · DXN
Lotusnine Medical Limited
Cardiovascular · 188d
Cleared Jan 27, 2022
Sim&Size
K212373 · PZO
Sim&Cure
Neurology · 181d
Cleared Jan 27, 2022
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay...
K213211 · DIO
Carolina Liquid Chemistries Corp.
Toxicology · 120d
Cleared Jan 27, 2022
Elevo Snoring Intervention Set
K213475 · LRK
Zelegent, Inc.
Dental · 90d