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

Filters: Cleared only ×
175,820 results
123313–123336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1991
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
K904690 · DWJ
Marquest Medical Products, Inc.
Cardiovascular · 108d
Cleared Feb 01, 1991
FIRM MASTER
K905195 · LKY
Bak Medical Products
Toxicology · 74d
Cleared Feb 01, 1991
IMMULITE (TM) TOTAL T3
K905214 · CDP
Cirrus Diagnostics, Inc.
Chemistry · 73d
Cleared Feb 01, 1991
DIAVENTIONAL CATHETER
K905297 · DQO
Cordis Corp.
Cardiovascular · 66d
Cleared Feb 01, 1991
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
K905407 · GZB
Medtronic Vascular
Neurology · 60d
Cleared Feb 01, 1991
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL
K905615 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Feb 01, 1991
SARNS INVENT CATHETERS
K905638 · DWF
3M Health Care, Sarns
Cardiovascular · 45d
Cleared Feb 01, 1991
ERCP CANNULA
K905714 · FGE
Everest Medical Corp.
Gastroenterology & Urology · 42d
Cleared Feb 01, 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727 · DQO
C.R. Bard, Inc.
Cardiovascular · 39d
Cleared Feb 01, 1991
CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION
K905858 · LNH
Medical Advances, Inc.
Radiology · 45d
Cleared Feb 01, 1991
MAXI-FLOW SUCTION SET 12 FT.
K910170 · GAZ
Adler Instrument Co.
General Hospital · 17d
Cleared Feb 01, 1991
MAXI-FLOW SUCTION SET W/Y CONNECTOR
K910171 · GAZ
Adler Instrument Co.
General Hospital · 17d
Cleared Feb 01, 1991
LIFE O2
K910201 · BTL
Life Corp.
Anesthesiology · 14d
Cleared Jan 31, 1991
DIGIGRAPH DIAGNOSTIC WORK/STATION
K896099 · EAG
Dolphin Imaging Systems
Radiology · 468d
Cleared Jan 31, 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623 · KNT
Abbott Laboratories
Gastroenterology & Urology · 231d
Cleared Jan 31, 1991
WALLACH FLEXIBLE ENDOMETRIAL SAMPLER
K902693 · HFF
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 226d
Cleared Jan 31, 1991
PC-BEADS POSTCOITAL TEST
K902995 · HHT
Microscopy Research Innovations
Obstetrics & Gynecology · 206d
Cleared Jan 31, 1991
AUTO FIRST-AID KIT FOR AMERICA
K903393 · LRR
Hisler-Radke, Inc.
General & Plastic Surgery · 188d
Cleared Jan 31, 1991
VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)
K903847 · LYZ
Zest Mark Industrial Co., Ltd.
General Hospital · 163d
Cleared Jan 31, 1991
SIL-MED T-TUBE DRAIN
K903989 · HFL
Sil-Med Corp.
Obstetrics & Gynecology · 155d
Cleared Jan 31, 1991
TRACET AG 4000
K904512 · DRX
Lectec Corp.
Cardiovascular · 121d
Cleared Jan 31, 1991
SURGICARE STERILE SURGICAL GLOVES
K904972 · KGO
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 99d
Cleared Jan 31, 1991
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K905000 · HEM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 85d
Cleared Jan 31, 1991
ORAL PHARYNGEAL CLEANSING DEVICE
K905011 · EIA
Concord/Portex
Dental · 85d