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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
169801–169824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
K791083 · CKA
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF ALT (GPT)
K791084 · CKA
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
K791085 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
CARY 210 SERIES, SPECTROPHOTOMETER
K791102 · JJQ
Varian Assoc., Inc.
Chemistry · 34d
Cleared Jul 17, 1979
CONTEXT FILTER
K791108 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 33d
Cleared Jul 17, 1979
MODEL CE-DM-II HEARING INSTRUMENT
K791126 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
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