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
153505–153528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1984
DEMAND OXYGEN CONTROLLER
K833351 · BZB
Healthdyne, Inc.
Anesthesiology · 173d
Cleared Mar 19, 1984
PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM
K833442 · LJS
Quinton, Inc.
General Hospital · 166d
Cleared Mar 19, 1984
MODIFIED HPS HIP PROSTHESIS
K833599 · KWL
Depuy, Inc.
Orthopedic · 159d
Cleared Mar 19, 1984
SURGICAL VESSEL DILATORS-CATHERIZA-
K833676 · DWP
Cimed Intl., Inc.
Cardiovascular · 157d
Cleared Mar 19, 1984
SANI CATCH BA
K833814 · LIO
Concord Laboratories, Inc.
Microbiology · 138d
Cleared Mar 19, 1984
HCG RIA
K833851 · JHI
Syncor Intl. Corp.
Chemistry · 136d
Cleared Mar 19, 1984
MELOLITE
K833954 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 124d
Cleared Mar 19, 1984
SERALYZER DRUG ASSAY CONTROL SERUM
K833977 · DLJ
Miles Laboratories, Inc.
Toxicology · 123d
Cleared Mar 19, 1984
SPINAL CORD STIMULATION SYS SE-4
K833990 · GZB
Medtronic Vascular
Neurology · 119d
Cleared Mar 19, 1984
PERCUTANEOUS SHEATH INTRODUCER TRAY
K834074 · DYB
Packaging Technologies, Inc.
Cardiovascular · 115d
Cleared Mar 19, 1984
ETHYLENE OXIDE DETECTOR GLD-1-07
K834152 · FLE
Calnor of EL Paseo, Inc.
General Hospital · 109d
Cleared Mar 19, 1984
DESERET SUBCLAVIAN JUGULAR CATH. SET
K834227 · FOZ
Parke-Davis Co.
General Hospital · 104d
Cleared Mar 19, 1984
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350 · FZX
Acufex Microsurgical, Inc.
General & Plastic Surgery · 97d
Cleared Mar 19, 1984
OK FLASH STERILIZATION INDICATOR
K834353 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 97d
Cleared Mar 19, 1984
OPHTEC RUST RING REMOVER
K834354 · HOG
Jedmed Instrument Co.
Ophthalmic · 97d
Cleared Mar 19, 1984
STERILE DISPOSABLE SPINAL NEEDLES
K834407 · FMI
Hydro-Med Products, Inc.
General Hospital · 96d
Cleared Mar 19, 1984
DISPOS. SCOTT CANNULAS 16-1054 ETC.
K834477 · HCA
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Mar 19, 1984
EMIT ST. URINE COCAINE METABOLITE
K834549 · DIO
Syva Co.
Toxicology · 83d
Cleared Mar 19, 1984
EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT
K834550 · LFG
Syva Co.
Toxicology · 83d
Cleared Mar 19, 1984
OXYMIZER-PENDANT
K834588 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 81d
Cleared Mar 19, 1984
ACCUFLEX
K834590 · JQW
Micromedic Systems
Chemistry · 81d
Cleared Mar 19, 1984
SOPHEIA T3 EIA KIT
K840050 · CDP
Diagnostic Products Corp.
Chemistry · 73d
Cleared Mar 19, 1984
EMIT ST URINE METHADONE ASSAY
K840060 · DJR
Syva Co.
Toxicology · 70d
Cleared Mar 19, 1984
EMIT ST URINE PHENCYCLIDINE ASSAY
K840061 · LCM
Syva Co.
Toxicology · 70d