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
123385–123408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1991
FETAL MONITORING SPIRAL ELECTRODE
K905130 · HGP
Graphic Controls Corp.
Obstetrics & Gynecology · 75d
Cleared Jan 29, 1991
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
K905761 · EJT
Argen Precious Metals, Inc.
Dental · 33d
Cleared Jan 29, 1991
ARGENCO 52HN
K905811 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM900 PP
K910096 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 HF
K910099 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 D
K910100 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 PP
K910101 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 PPL
K910102 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 HF
K910103 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
AM130 AGC-O (BEHIND THE EAR) HEARING AID
K910148 · ESD
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 28, 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · NAD
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 279d
Cleared Jan 28, 1991
HALA'TUS 1 OXYGENATOR
K903504 · NFB
The Henry G. Dietz Co., Inc.
Anesthesiology · 178d
Cleared Jan 28, 1991
RAPITEX(R) ASL NEW
K903854 · GTQ
Behring Diagnostics, Inc.
Microbiology · 160d
Cleared Jan 28, 1991
DYNATECH MR4000 MICROPLATE READER
K904567 · JJQ
Dynatech Corp.
Microbiology · 111d
Cleared Jan 28, 1991
BOBBIN STYLE VENTURI
K904592 · ETD
River Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Jan 28, 1991
COLLAR BUTTON STYLE VENTURI
K904594 · ETD
River Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Jan 28, 1991
GROMMET STYLE VENTURI
K904597 · ETD
River Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Jan 28, 1991
SENSITOUCH
K904769 · KGO
Ansell Intl.
General Hospital · 98d
Cleared Jan 28, 1991
DIAGNOSTIC ULTRASOUND VERSADOPP 1000
K904792 · DPW
Diagnostic Ultrasound Corp.
Cardiovascular · 97d
Cleared Jan 28, 1991
BEUCHEL-PAPPAS GLENOID COMPONENT
K904879 · KWS
Endotec, Inc.
Orthopedic · 90d
Cleared Jan 28, 1991
BUECHEL-PAPPAS HUMERAL STEM COMPONENT
K904880 · KWS
Endotec, Inc.
Orthopedic · 90d
Cleared Jan 28, 1991
I/A VITROPHAGE MODEL YPR 2001
K904909 · HQE
Visioncare Devices, Inc.
Ophthalmic · 89d
Cleared Jan 28, 1991
THAYER MIP ADAPTER
K904917 · BXR
Thayer Medical Corp.
Anesthesiology · 89d
Cleared Jan 28, 1991
HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL
K904967 · FKP
Gambro-Hosp-Cobe, Inc.
Gastroenterology & Urology · 84d