FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74041–74064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 2002
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL...
K002612 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 743d
Cleared Sep 03, 2002
EYEFEEL OPHTHALMIC WARMER
K021843 · IMD
Bio-Lipid, Inc.
Physical Medicine · 90d
Cleared Sep 03, 2002
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
K021847 · FCG
Biopsy Sciences, LLC
Gastroenterology & Urology · 90d
Cleared Sep 03, 2002
CLARUS STRAIGHT FIRING LASER FIBER
K021848 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 90d
Cleared Sep 03, 2002
LUCIUS 62
K021948 · EJT
Lucius Metals Com.
Dental · 82d
Cleared Sep 03, 2002
SYNTHES MIDFACE DISTRACTOR
K022005 · JEY
Synthes (Usa)
Dental · 76d
Cleared Sep 03, 2002
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
K022042 · DWF
Cardeon Corp.
Cardiovascular · 71d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
K022088 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
K022090 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K022092 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
K022146 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Sep 03, 2002
RAICHEM LIPID CALIBRATOR
K022767 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 13d
Cleared Aug 30, 2002
SLEEPFLO, MODEL 101501
K020607 · MNR
Biomec, Inc.
Anesthesiology · 186d
Cleared Aug 30, 2002
VERACAM
K021083 · EIA
Lumalite, Inc.
Dental · 149d
Cleared Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU,...
K021162 · JPA
Sigma Diagnostics, Inc.
Hematology · 141d
Cleared Aug 30, 2002
DATEX-OHMEDA HMEF 500
K021265 · CAH
Datex-Ohmeda
General Hospital · 130d
Cleared Aug 30, 2002
ENDOSSEOUS IMPLANT
K021355 · DZE
Branemark Integration AB
Dental · 123d
Cleared Aug 30, 2002
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
K021493 · KNT
Andersen Products, Inc.
Gastroenterology & Urology · 113d
Cleared Aug 30, 2002
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE...
K021781 · CGA
Chay Medical, LLC
Chemistry · 92d
Cleared Aug 30, 2002
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
K021837 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 30, 2002
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K022543 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Aug 30, 2002
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 28d
Cleared Aug 30, 2002
PVP (POLYVINYLPYRROLIDONE)
K022590 · MQL
Intl., Inc.
Obstetrics & Gynecology · 25d