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
26665–26688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2018
Remedy Acetabular Cup
K173967 · KWL
Osteoremedies, LLC
Orthopedic · 55d
Cleared Feb 22, 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · LPL
Menicon Co, Ltd.
Ophthalmic · 51d
Cleared Feb 22, 2018
Natus Quantum
K180181 · GWQ
Natus Medical Incorporated Dba...
Neurology · 30d
Cleared Feb 21, 2018
Captura Disposable Bronchoscope Biopsy Forceps
K163377 · EOQ
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 447d
Cleared Feb 21, 2018
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
K170866 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 335d
Cleared Feb 21, 2018
PiCCO Catheter
K171620 · KRB
Pulsion Medical Systems SE
Cardiovascular · 264d
Cleared Feb 21, 2018
Catasyn Advanced Technology Wound Hydrogel
K172338 · FRO
Synedgen, Inc.
General & Plastic Surgery · 203d
Cleared Feb 21, 2018
Reprocessed ArthroCare ENT Coblator
K172647 · NUJ
Renovo, Inc.
General & Plastic Surgery · 173d
Cleared Feb 21, 2018
TSN Transseptal Needle
K172950 · DRC
Pressure Products Medical Device...
Cardiovascular · 148d
Cleared Feb 21, 2018
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
K173626 · FRC
STERIS Corporation
General Hospital · 89d
Cleared Feb 21, 2018
CELERITY 20 Steam Process Challenge Device for Gravity Cycles
K173629 · FRC
STERIS Corporation
General Hospital · 89d
Cleared Feb 21, 2018
DRI Benzodiazepine Assay
K173963 · JXM
Microgenics Corporation
Toxicology · 55d
Cleared Feb 21, 2018
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
K180193 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 28d
Cleared Feb 20, 2018
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
K170683 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 350d
Cleared Feb 20, 2018
Elecsys CA 15-3 II
K171605 · MOI
Roche Diagnostics
Immunology · 264d
Cleared Feb 20, 2018
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry...
K172423 · DQE
Edwards Lifescience, LLC
Cardiovascular · 194d
Cleared Feb 20, 2018
HydroPICC
K172885 · LJS
Access Vascular, Inc.
General Hospital · 152d
Cleared Feb 20, 2018
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
K173228 · LZA
Jiangsu U-Med Rubber & Plastic...
General Hospital · 139d
Cleared Feb 20, 2018
Tri-Staple 2.0 Reinforced Reload
K173270 · GDW
Covidien
General & Plastic Surgery · 131d
Cleared Feb 20, 2018
WS80A Diagnostic Ultrasound System
K173513 · IYN
Samsung Medison Co., Ltd.
Radiology · 99d
Cleared Feb 20, 2018
SeaSpine NewPort Spinal System
K180176 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared Feb 18, 2018
Optima Coil System
K172390 · HCG
Blockade Medical, LLC (D.B.A. Balt Usa)
Neurology · 194d
Cleared Feb 16, 2018
DUS R-50S (Urine Chemistry system)
K171521 · JIL
DFI Co., Ltd.
Chemistry · 268d
Cleared Feb 16, 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
K171600 · KOD
Cook Incorporated
Gastroenterology & Urology · 260d