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
128665–128688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1989
TRU-TOUCH VINYL, NON-STERILE
K891719 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 259d
Cleared Dec 05, 1989
TAGUM LATEX EXAMINATION GLOVES
K892073 · LYY
Tagum Rubber Industries, Ltd.
General Hospital · 246d
Cleared Dec 05, 1989
TRU-TOUCH VINYL, STERILE
K892327 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 259d
Cleared Dec 05, 1989
FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES
K892328 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 259d
Cleared Dec 05, 1989
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
K892926 · LJS
Vas-Cath, Inc.
General Hospital · 228d
Cleared Dec 05, 1989
LATEX EXAMINATION GLOVES
K893357 · LYY
M.M. Rubber Co. , Ltd.
General Hospital · 225d
Cleared Dec 05, 1989
ECG SIMULATOR MODEL ECGPLUS
K893660 · DPS
Bio-Tek Instruments, Inc.
Cardiovascular · 204d
Cleared Dec 05, 1989
PATIENT EXAMINATION GLOVES
K894308 · LYY
Xing Huao Co. , Ltd.
General Hospital · 165d
Cleared Dec 05, 1989
IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
K894748 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d
Cleared Dec 05, 1989
LATEX EXAMINATION GLOVES
K895322 · LYY
Advantage Resources
General Hospital · 98d
Cleared Dec 05, 1989
LATEX PATIENT EXAMINATION GLOVES
K895642 · OPE
Siam Sempermed Corp., Ltd.
General & Plastic Surgery · 77d
Cleared Dec 05, 1989
IMPEDANCE ANALYZER MODELS MD-2, MD-P
K895783 · ETY
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d
Cleared Dec 05, 1989
IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
K895784 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d
Cleared Dec 05, 1989
AUDIOMETER MODEL MD-4, MD-4P
K895785 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d
Cleared Dec 05, 1989
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS
K895821 · KNK
Catachem, Inc.
Chemistry · 67d
Cleared Dec 05, 1989
SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
K895850 · JGG
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Dec 05, 1989
NON-STERILE LATEX EXAMINATION GLOVES
K896220 · LYY
Allstar Sdn. Bhd.
General Hospital · 36d
Cleared Dec 05, 1989
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
K896347 · LJM
General Biometrics, Inc.
Immunology · 32d
Cleared Dec 04, 1989
POLYETHER-RETARDER
K892412 · ELW
Espe GmbH (Us)
Dental · 238d
Cleared Dec 04, 1989
KULZER GLAS-IONOMER CEMENT
K892453 · EMA
Kulzer, Inc.
Dental · 238d
Cleared Dec 04, 1989
AQUATREX UNDERWATER TREADMILL SYSTEM
K895104 · IOL
Edmonds Medical Systems
Physical Medicine · 111d
Cleared Dec 04, 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · DTZ
3M Company
Cardiovascular · 90d
Cleared Dec 04, 1989
NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM
K895401 · EBF
Rocky Mountain Orthodontics, Inc.
Dental · 88d
Cleared Dec 04, 1989
ALCON FOLDING FORCEPS
K895434 · HNR
Alcon Laboratories
Ophthalmic · 87d