Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
142369–142392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 06, 1986
NATURAL DETECTOR SYSTEM
K861731 · KHE
U.S. Health Resources Corp.
Hematology · 184d
Cleared Nov 06, 1986
PIASTRINIT
K863114 · GGK
J. D. Assoc.
Hematology · 85d
Cleared Nov 06, 1986
AMICON DIAFILTER HEMOFILTER
K863823 · KDI
Amicon, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 06, 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · FKP
Gambro, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 06, 1986
PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)
K864167
Datascope Corp.
Cardiovascular · 13d
Cleared Nov 06, 1986
FRESENIUS HEMOFLOW F50 & F70
K864169 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 13d
Cleared Nov 05, 1986
MONO ACU-SLIDE TEST
K861211 · JHJ
Cal-Tech Diagnostics, Inc.
Chemistry · 219d
Cleared Nov 05, 1986
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT
K861425 · DZE
Core-Vent Corp.
Dental · 203d
Cleared Nov 05, 1986
SERUM CLONAZEPAM TOXICOLOGY CONTROL
K862421 · LAS
Utak Laboratories, Inc.
Toxicology · 133d
Cleared Nov 05, 1986
OXOID SIGNAL BLOOD CULTURE SYSTEM
K862946 · JSG
Oxoid U.S.A., Inc.
Microbiology · 92d