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
172057–172080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1977
SCANNER, CT, 0400
K772289 · JAK
Pfizer Medical Systems, Inc.
Radiology · 9d
Cleared Dec 21, 1977
DIAG. CONSOLE, INDEPENDENT
K772291 · JAK
Pfizer, Inc.
Radiology · 9d
Cleared Dec 21, 1977
TRANSPARENT MANIFOLD
K772299 · DTL
Uni-Research
Cardiovascular · 8d
Cleared Dec 20, 1977
SWAN GANZ
K771043 · DYG
Clincal Instruments Corp.
Cardiovascular · 194d
Cleared Dec 20, 1977
PEDIATRIC INFUSION T
K771426 · FKB
Quinton, Inc.
Gastroenterology & Urology · 141d
Cleared Dec 20, 1977
PEDIATRIC THYROXINE TEST SYS. T4
K771609 · CDX
Corning Medical & Scientific
Chemistry · 120d
Cleared Dec 20, 1977
SUCTION CANISTER
K771737 · GCX
Bemis Health Care
General Hospital · 96d
Cleared Dec 20, 1977
CATHETER, CARDIOVASCULAR
K771823 · DYG
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Dec 20, 1977
DUAL WAVELENGTH PHOTOMETER, 1177
K771909 · JJQ
Abbott Laboratories
Immunology · 70d
Cleared Dec 20, 1977
PROTECT IV GARD
K772060 · FMP
Omnicon Medical Corp.
General Hospital · 50d
Cleared Dec 20, 1977
PULLEN PLASTIC-PORE PLUGS
K772066 · ETD
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 49d
Cleared Dec 20, 1977
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS
K772098 · DON
Bd Becton Dickinson Vacutainer...
Immunology · 43d
Cleared Dec 20, 1977
TOTAL HIP, CHARNELY TYPE
K772120 · JDG
Depuy, Inc.
Orthopedic · 41d
Cleared Dec 20, 1977
PERITONEAL CYCLER & MANIFOLD SET
K772136 · KDJ
Physio-Control Corp.
Gastroenterology & Urology · 36d
Cleared Dec 20, 1977
ENDOTRACHEAL TUBE
K772138 · BTO
Medline Industries, Inc.
Anesthesiology · 36d
Cleared Dec 20, 1977
CYSTIC FIBROSIS TESTING INSTRUMENT
K772176 · JJN
Laboratory Equipment Design Co.
Chemistry · 29d
Cleared Dec 20, 1977
EMIT ANTIEPILEPTIC DRUG ASSAYS
K772179 · DIP
Syva Co.
Toxicology · 27d
Cleared Dec 20, 1977
PROPHYLACTIC
K772181 · HIS
Om Industries, Inc.
Obstetrics & Gynecology · 25d
Cleared Dec 20, 1977
THYROID BINDING GLOBULIN
K772183 · CEE
Corning Medical & Scientific
Immunology · 25d
Cleared Dec 20, 1977
HEARING AID, BODY TYPE, MODEL H
K772201 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared Dec 20, 1977
PULSE GENERATOR, A-V SEQ.
K772202 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Dec 20, 1977
CULTURE COLLEC. TRANS. SYS., SINGLE WET
K772207 · JTW
Precision Dynamics Corp.
Microbiology · 19d
Cleared Dec 20, 1977
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY
K772209 · JTW
Precision Dynamics Corp.
Microbiology · 19d
Cleared Dec 20, 1977
CATH KIT, SUPERPUBIC
K772227 · KXF
American Hospital Supply Corp.
General Hospital · 14d