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
17233–17256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2021
ClotTriever Thrombectomy System
K210689 · QEW
Inari Medical, Inc.
Cardiovascular · 65d
Cleared May 12, 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K210737 · MED
STERIS Corporation
General Hospital · 62d
Cleared May 12, 2021
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
K210809 · JWH
Conformis, Inc.
Orthopedic · 56d
Cleared May 12, 2021
High Performance Antimicrobial Gelling Fiber with Silver
K210974 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 41d
Cleared May 11, 2021
HD Mediastinoscope
K202272 · EWY
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 273d
Cleared May 11, 2021
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D,...
K202860 · HQD
Valley Contax, Inc.
Ophthalmic · 225d
Cleared May 11, 2021
HANAROSTENT Benefit Biliary (NNN)
K202973 · FGE
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 223d
Cleared May 11, 2021
DART-FIRE EDGE Cannulated Screw System
K203228 · HWC
Wright Medical
Orthopedic · 190d
Cleared May 11, 2021
Neurodyn V2.0, Neurodyn Aussie V2.0
K210572 · IPF
Ibramed Equipamentos Medicos
Physical Medicine · 74d
Cleared May 11, 2021
Air Pressure Therapy System: VU-IPC06
K210967 · IRP
Xiamen Weiyou Intelligent Technology...
Physical Medicine · 41d
Cleared May 10, 2021
Solax Electric Scooter (Models: S204311M, S204161, S204143)
K190737 · INI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 780d
Cleared May 10, 2021
Yumizen C1200 Creatinine PAP
K193649 · JFY
HORIBA ABX SAS
Chemistry · 497d
Cleared May 10, 2021
Single-use medical poly (vinyl chloride) examination glove
K201504 · LYZ
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 339d
Cleared May 10, 2021
ChoiceSpine Blackhawk Ti Cervical Spacer System
K203311 · OVE
Choice Spine, LLC
Orthopedic · 181d
Cleared May 10, 2021
Endo Motor
K203320 · EKX
Guilin Woodpecker Medical Instrument...
Dental · 179d
Cleared May 10, 2021
Diode Laser Therapy Systems
K210168 · GEX
Beijing Kes Biology Technology Co., Ltd.
General & Plastic Surgery · 108d
Cleared May 07, 2021
Bigfoot Unity Diabetes Management System
K202145 · QLG
Bigfoot Biomedical, Inc.
Chemistry · 280d
Cleared May 07, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036 · LZA
Central Medicare Sdn Bhd
General Hospital · 214d
Cleared May 07, 2021
Karl Storz Radel Sterilization Trays
K203572 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 151d
Cleared May 07, 2021
FuseForce™ Flex Dynamic Compression System
K203832 · JDR
Wright Medical
Orthopedic · 128d
Cleared May 07, 2021
Reprocessed Tri Pulse Compression Garment
K203847 · JOW
Renu Medical, Inc.
Cardiovascular · 127d
Cleared May 07, 2021
SURGICAL MASK, Model Name:C015
K210218 · FXX
Qingdao Hainuo Biological Engineering...
General Hospital · 100d
Cleared May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366 · LZA
Onetexx Sdn Bhd
General Hospital · 88d
Cleared May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · LZA
Meditech Gloves Sdn Bhd
General Hospital · 53d