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
112705–112728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1993
DUALTHERM(R) CARDIAC OUTPUT COMPUTER
K925285 · DQK
B. Braun of America, Inc.
Cardiovascular · 274d
Cleared Jul 21, 1993
TOTAL FACE MASK
K925920 · BZD
Respironics, Inc.
Anesthesiology · 240d
Cleared Jul 21, 1993
ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO
K926301 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 218d
Cleared Jul 21, 1993
CVIS INSIGHT IMAGING GUIDE CATHETER
K930232 · DQO
Cardiovascular Imaging Systems, Inc.
Radiology · 183d
Cleared Jul 21, 1993
WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM
K930888 · DRS
Ralin Medical, Inc.
Cardiovascular · 152d
Cleared Jul 21, 1993
PEDO JACKETS OR PJ'S
K931352 · ELZ
George M. Wilson, Dds
Dental · 126d
Cleared Jul 21, 1993
3M MEDICAL DIAGNOSTIC VIDEOCASSETTE
K931604 · IWZ
3M Health Care, Ltd.
Radiology · 111d
Cleared Jul 21, 1993
TREATMENT TABLES, MANUALLY ACTIVATED
K931635 · INW
Med Mart, Inc.
Physical Medicine · 111d
Cleared Jul 21, 1993
VENTRI-CATH
K931989 · JXG
Gesco Intl., Inc.
Neurology · 90d
Cleared Jul 21, 1993
BOVIE ULTRASONIC SURGICAL ASPIRATOR
K932094 · LFL
Mdt Corp., Inc.
General & Plastic Surgery · 82d
Cleared Jul 21, 1993
COWBOY III
K932215 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 75d
Cleared Jul 21, 1993
TREATMENT TABLES, ELECTRICALLY ACTIVATED
K932412 · INQ
Med Mart, Inc.
Physical Medicine · 111d
Cleared Jul 21, 1993
PRISM
K932480 · IOQ
Bio Clinic Co.
Physical Medicine · 58d
Cleared Jul 21, 1993
PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT
K932486 · CAI
Precision Med Products, Ltd.
Anesthesiology · 58d
Cleared Jul 21, 1993
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K932583 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 55d
Cleared Jul 21, 1993
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K932588 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 55d
Cleared Jul 21, 1993
EAR CURETTE
K932609 · JYG
Ear Tech, Inc.
Ear, Nose, Throat · 54d
Cleared Jul 21, 1993
MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE
K932746 · INQ
Tri W-G, Inc.
Physical Medicine · 43d
Cleared Jul 20, 1993
MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
K920429 · MLD
Hewlett-Packard Co.
Cardiovascular · 533d
Cleared Jul 20, 1993
URO-PRO 2000
K922476 · FAP
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 420d
Cleared Jul 20, 1993
FST COUNCIL TIP FOLEY CATHETER
K922776 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 406d
Cleared Jul 20, 1993
CC ARHYTHMIS MONITORING OPTION
K923747 · DSI
Hewlett-Packard Co.
Cardiovascular · 376d
Cleared Jul 20, 1993
BAXTER SOLUTION ADMINISTRATION SETS
K924721 · FPA
Baxter Healthcare Corp
General Hospital · 302d
Cleared Jul 20, 1993
MATRIX CCM 600
K926009 · IYO
Heraeus Kulzer, Inc.
Radiology · 230d