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
17953–17976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2021
EZ-Injec LDV Sterile Safety Needle
K210444 · QNS
Poonglim Pharmatech, Inc.
General Hospital
Cleared Feb 15, 2021
740 SafeSAT
K200160 · MWI
Zoe Medical, Inc.
Cardiovascular · 390d
Cleared Feb 12, 2021
Straumann Variobase C
K192742 · NHA
Institut Straumann AG
Dental · 501d
Cleared Feb 12, 2021
MedCAD® AccuPlate® Patient-Specific Plate
K193280 · JEY
Medcad
Dental · 443d
Cleared Feb 12, 2021
MectaLIF Transforaminal TiPEEK
K200551 · MAX
Medacta Inernational SA
Orthopedic · 346d
Cleared Feb 12, 2021
Plastic LOR Syringe
K201356 · CAZ
Jiangsu Caina Medical Co.,Ltd
Anesthesiology · 267d
Cleared Feb 12, 2021
Electro Flo 6 Airway Clearance System
K201490 · BYI
Med Systems, Inc.
Anesthesiology · 253d
Cleared Feb 12, 2021
Surgical Face Mask
K201545 · FXX
Amphastar Nanjing Pharmaceuticals, Inc.
General Hospital · 248d
Cleared Feb 12, 2021
Panda iRes Warmer, Giraffe Warmer
K201628 · FMT
Ge Healthcare
General Hospital · 241d
Cleared Feb 12, 2021
CleaniCal
K201799 · EJK
Maruchi
Dental · 227d
Cleared Feb 12, 2021
EDS Bioceramic Sealer (Bioseal)
K202281 · KIF
Essential Dental Systems
Dental · 184d
Cleared Feb 12, 2021
Disposable Surgical Mask
K202341 · FXX
Shanghai Jianzhong Medical Packaging...
General Hospital · 179d
Cleared Feb 12, 2021
Infrared Thermometer
K202368 · FLL
Shandong Bittel Intelligent...
General Hospital · 177d
Cleared Feb 12, 2021
Catalyst OrthoScience R1 Reverse Shoulder System
K202611 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 156d
Cleared Feb 12, 2021
NOA Sleep Apnea and Snoring Device
K202651 · LRK
Orthoapnea S.L.
Dental · 151d
Cleared Feb 12, 2021
MucoLock Oral Gel
K203091 · OLR
Pcca, Inc.
Dental · 122d
Cleared Feb 12, 2021
LYDUS Nitrile Examination Gloves, Powder Free
K203191 · LZA
Nathan Trading Co., Ltd.
General Hospital · 108d
Cleared Feb 12, 2021
Straumann TLX Novaloc and Cementable Abutments
K203355 · NHA
Institut Straumann AG
Dental · 88d
Cleared Feb 12, 2021
gammaCore Sapphire
K203546 · PKR
Electrocore, Inc.
Neurology · 70d
Cleared Feb 12, 2021
Vinyl Examination Gloves (Yellow)
K203702 · LYZ
Xinying Trading Co., Ltd.
General Hospital · 56d
Cleared Feb 12, 2021
JuggerKnot Soft Anchor
K203740 · MBI
Riverpoint Medical
Orthopedic · 52d
Cleared Feb 12, 2021
4D Integrated Treatment Console
K203766 · MUJ
Varian Medical Systems, Inc.
Radiology · 51d
Cleared Feb 11, 2021
DSP Implant System
K192839 · DZE
D.S.P Industrial Eireli
Dental · 504d
Cleared Feb 11, 2021
Ezlymph, Ezlymph M
K193662 · JOW
Eezcare Medical Corp
Cardiovascular · 408d