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
26809–26832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2018
IMD's Lumbar Puncture Needle
K170112 · BSP
International Medical Development,...
Anesthesiology · 386d
Cleared Feb 02, 2018
KARL STORZ Slim Nasopharyngolaryngoscope
K171402 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 266d
Cleared Feb 02, 2018
OralTox Oral Fluid Drug Test
K171403 · DJC
Premier Biotech, Inc.
Toxicology · 266d
Cleared Feb 02, 2018
Glooko Mobile Insulin Dosing System
K171450 · NDC
Glooko, Inc.
General Hospital · 261d
Cleared Feb 02, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 214d
Cleared Feb 02, 2018
The Plateau-LO Spacer System
K172105 · MAX
Life Spine, Inc.
Orthopedic · 205d
Cleared Feb 02, 2018
Bicera Resorbable Bone Substitute
K172237 · MQV
Wiltrom Corporation Limited
Orthopedic · 192d
Cleared Feb 02, 2018
ACRO HCG Pregnancy Rapid Test
K172512 · LCX
Acro Biotech, Inc.
Chemistry · 165d
Cleared Feb 02, 2018
Materialise TKA Guide System
K173445 · JWH
Materialise NV
Orthopedic · 88d
Cleared Feb 02, 2018
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
K173800 · MQP
Camber Spine Technologies
Orthopedic · 50d
Cleared Feb 02, 2018
Triathlon Total Knee System
K173849 · MBH
Stryker Orthopaedics
Orthopedic · 45d
Cleared Feb 02, 2018
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K173981 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 35d
Cleared Feb 02, 2018
SMAXEL CO2 Surgical Laser System
K180036 · ONG
Ids, Ltd.
General & Plastic Surgery · 28d
Cleared Feb 02, 2018
SpeediCath Flex Coude Pro
K180070 · GBM
Coloplast
Gastroenterology & Urology · 24d
Cleared Feb 01, 2018
PREMIUM Implant Systems SHELTA Implant Systems
K161989 · NHA
Sweden & Martina S.P.A.
Dental · 562d
Cleared Feb 01, 2018
Sporview VH202 BI
K171287 · FRC
Spsmedical Supply Corp. A Division of...
General Hospital · 276d
Cleared Feb 01, 2018
Micromed BRAIN QUICK system
K171384 · GWQ
Micromed S.P.A.
Neurology · 266d
Cleared Feb 01, 2018
ABCcolla Bone Graft
K171629 · MQV
Acro Biomedical Co., Ltd.
Orthopedic · 244d
Cleared Feb 01, 2018
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip...
K171662 · KOD
Cook Incorporated
Gastroenterology & Urology · 241d
Cleared Feb 01, 2018
MERISTEEL
K172146 · GAQ
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 199d
Cleared Feb 01, 2018
Duatene bilayer mesh
K172395 · FTL
Sofradim Production
General & Plastic Surgery · 177d
Cleared Feb 01, 2018
Sentosa SA201 HSV 1/2 Qualitative PCR Test
K172509 · OQO
Vela Diagnostics USA, Inc.
Microbiology · 164d
Cleared Feb 01, 2018
Specimen Retrieval Bag
K172789 · GCJ
Beijing Hangtian Kadi Technology R&D...
General & Plastic Surgery · 139d
Cleared Feb 01, 2018
Double Medical Cage System
K172828 · MAX
Double Medical Technology, Inc.
Orthopedic · 136d