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
168961–168984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1979
PERMANENT LEAD INTRADUCER
K791129 · DYB
Daig Corp.
Cardiovascular · 33d
Cleared Jul 17, 1979
SICKLE-CELL F TEST
K791143 · KQI
Isolab, Inc.
Hematology · 29d
Cleared Jul 17, 1979
TRYPTIC SOY BROTH
K791171 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
ECHO CARDIOGRAM PAD
K791189 · FNJ
Alimed, Inc.
General Hospital · 21d
Cleared Jul 17, 1979
NUTRIENT BROTH
K791193 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
BRAIN HEART INFUSION BROTH
K791194 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
BRAIN HEART INFUSION WITH BROTH
K791291 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
BRAIN HEART INFUSION WITH AGAR BROTH
K791292 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 12, 1979
SWAN-GANZ FLOW-DIRECTED CATHETER
K791183 · LDF
Edwards Lifesciences, LLC
Cardiovascular · 17d
Cleared Jul 11, 1979
SURG-O-PAK, GOWNS, SHEETS, AND TOWELS
K780627 · KKX
Convertors
General Hospital · 453d
Cleared Jul 10, 1979
SENSOMAT SIDEARM ADAPTER
K790597 · KGZ
Biochem International, Inc.
General & Plastic Surgery · 106d
Cleared Jul 10, 1979
BIFLEX TM TEMPORARY PACING PROBE
K790983 · DTB
Advanced Medical Concepts, Inc.
Cardiovascular · 46d
Cleared Jul 10, 1979
HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC
K791054 · DXN
C.R. Bard, Inc.
Cardiovascular · 33d
Cleared Jul 10, 1979
SHERWOOD NEBULIZER KIT
K791089 · CAF
Sherwood Medical Co.
Anesthesiology · 28d
Cleared Jul 10, 1979
MIDDLE EAR PICKS, HOOKS CURETTES,
K791120 · GDG
Xomed, Inc.
General & Plastic Surgery · 25d
Cleared Jul 10, 1979
TISSURE RETRACTORS
K791122 · GAD
Xomed, Inc.
General & Plastic Surgery · 25d
Cleared Jul 10, 1979
EAR AND NOSE SPECULA
K791123 · EPY
Xomed, Inc.
General & Plastic Surgery · 25d
Cleared Jul 10, 1979
PREGELLED DISPOSABLE ECG ELECTRODES
K791139 · DRX
Hayes Products, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
PREGELLED DISPOSABLE EELCTRO. SERIES 600
K791140 · DRX
Hayes Products, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
CPR CONTROL SYSTEM
K791145 · DRM
Pepin Distributing, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
ARCOLITH 4000
K791165 · DXY
Arco Medical Products Co.
Cardiovascular · 15d
Cleared Jul 10, 1979
DEXIDE DISPOSABLE PREP SPONGE
K791166 · NAB
Dexide, Inc.
General & Plastic Surgery · 15d
Cleared Jul 06, 1979
FISSURE SEALER AND BONDING AGENT
K790788 · EBC
Scientific Pharmaceuticals, Inc.
Dental · 73d
Cleared Jul 06, 1979
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
K790789 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 73d