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
141769–141792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1986
TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
K864161 · BTR
Toob-Cheq, Inc.
Anesthesiology · 18d
Cleared Nov 07, 1986
NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER
K855177 · DXN
Philips Park
Cardiovascular · 316d
Cleared Nov 07, 1986
DECITEL AUSCULSCOPE
K860994 · DQD
Bloomfield Research and Development,...
Cardiovascular · 235d
Cleared Nov 07, 1986
BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE
K861435 · CAW
The John Bunn Co.
Anesthesiology · 204d
Cleared Nov 07, 1986
SCHEIN AP-1 AIR POLISHING UNIT
K862384 · KOJ
Henry Schein, Inc.
Dental · 136d
Cleared Nov 07, 1986
ECG MODULE
K862553 · DPS
Elscint, Inc.
Cardiovascular · 127d
Cleared Nov 07, 1986
TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
K862919 · KFZ
Transpirator Technologics, Inc.
Anesthesiology · 98d
Cleared Nov 07, 1986
COOK-VPI INTERMITTENT CATHETER
K863082 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 07, 1986
BIOCHEM CO/OX 1000
K863186 · DQA
Biochem International, Inc.
Anesthesiology · 80d
Cleared Nov 07, 1986
VENT-PLANT DENTAL IMPLANT, OSSEOLOCK AND ROBUTMENT
K863755 · DZE
Vent-Plant Corporation, Inc.
Dental · 43d
Cleared Nov 07, 1986
NPG NONPRECIOUS CROWN AND BRIDGE ALLOY
K863782 · EJH
Aalba Dent, Inc.
Dental · 42d
Cleared Nov 07, 1986
COLBY LEVEL ALARM
K863955 · BTT
Respiratory Care, Inc.
Anesthesiology · 28d
Cleared Nov 07, 1986
CUSTOM IN-THE-EAR
K863975 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 24d
Cleared Nov 07, 1986
EYE PAD, COTTON, GAUZE COVERED
K864023
Fraass Survival Systems, Inc.
General & Plastic Surgery · 23d
Cleared Nov 07, 1986
PORTABLE OXYGEN GENERATOR
K864045 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 22d
Cleared Nov 07, 1986
ADEC 1005-C CHAIR
K864072 · LGX
Cherne Industries, Inc.
General Hospital · 18d
Cleared Nov 07, 1986
PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
K864087 · BTY
Medical Associated Services, Inc.
Anesthesiology · 17d
Cleared Nov 07, 1986
HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA
K864089 · FLL
Hitachi Sales Corporation of America
General Hospital · 17d
Cleared Nov 07, 1986
GAMBRO FLUID CONTROL MONITOR FCM 10-1
K864094 · FKP
Gambro, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 07, 1986
LUNG MECHANICS SOFTWARE PROGRAM
K864105 · CBK
Siemens Elema AB
Anesthesiology · 17d
Cleared Nov 07, 1986
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU
K864115 · KGZ
Cathaid, Inc.
General & Plastic Surgery · 28d
Cleared Nov 07, 1986
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
K864137 · KIJ
Bio-Rad
Immunology · 17d
Cleared Nov 07, 1986
NESBIT EVANS NURSING HOME BED
K864203 · FNJ
J. Nesbit Evans & Co.
General Hospital · 11d
Cleared Nov 06, 1986
SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR
K860734 · DPS
Marquette Electronics, Inc.
Cardiovascular · 252d