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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147913–147936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1985
ZIONOMER CEMENT
K852196 · EMA
Den-Mat Corp.
Dental · 31d
Cleared Jun 20, 1985
VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR
K852275 · CCL
Vascular Technology Incorporated
Anesthesiology · 22d
Cleared Jun 20, 1985
INOX IV STAND
K852300 · FOX
Broadwest Corp.
General Hospital · 22d
Cleared Jun 20, 1985
SEA-LONG NECKSEAL & HOOD
K852345 · BYL
Safety Sea Systems, Inc.
Anesthesiology · 20d
Cleared Jun 20, 1985
LIGHT REFLECTION RHEOGRAPHY
K852378 · DSB
Hemodynamics, Inc.
Cardiovascular · 15d
Cleared Jun 19, 1985
DENTAL ORAL CARE SYSTEMS & COMPONENTS
K844480 · EBO
Advanced Bio Systems, Inc.
Dental · 212d
Cleared Jun 19, 1985
WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
K844637 · LTC
Dow Corning Corp. Healthcare...
Chemistry · 203d
Cleared Jun 19, 1985
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
K850015 · DXE
Polymed Laboratories
Cardiovascular · 168d
Cleared Jun 19, 1985
MDI 2000 - PULSE GENERATOR
K850791 · DRO
Micromedical Devices, Inc.
Cardiovascular · 113d
Cleared Jun 19, 1985
CRESTLINE CL IN-THE-EAR HEARING AID
K850980 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 100d
Cleared Jun 19, 1985
ORTHOTRON MUSCLE STIMULATOR MK II DC
K851037 · IPF
Hodgkinson & Corby , Ltd.
Physical Medicine · 97d
Cleared Jun 19, 1985
MODEL BION 1/TYPE 1084T CAR IONIZER
K851094 · FRF
Medicor USA , Ltd.
General Hospital · 92d
Cleared Jun 19, 1985
TERRAN BIOMECHANICAL ANALYSIS SYSTEM
K851133 · LDK
Terran Biomedical Instruments
Physical Medicine · 90d
Cleared Jun 19, 1985
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140 · DWS
Teleflexmedical, Inc.
Cardiovascular · 90d
Cleared Jun 19, 1985
COBE GAS FILTER
K851289 · KRI
Cobe Laboratories, Inc.
Cardiovascular · 79d
Cleared Jun 19, 1985
CARNATION - OXYGEN MASK
K851466 · BYG
Dadsun Corp., Ltd.
Anesthesiology · 69d
Cleared Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
K851613 · KFM
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY
K851614 · DTQ
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE
K851615 · DTQ
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
BIO MEDICUS BIO PUMP MODEL BP-90
K851855 · KFM
Bio Medicus, Inc.
Cardiovascular · 54d
Cleared Jun 19, 1985
MEDTRONIC 5064
K851890 · DTD
Medtronic Vascular
Cardiovascular · 50d
Cleared Jun 19, 1985
MANAN PTC BIOPSY TRAYS
K852104
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 35d
Cleared Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 35d