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
146929–146952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1985
PORTABLE GASEOUS OXGYEN CONTAINER
K852663 · CAN
Cryogenic Assoc.
Anesthesiology · 66d
Cleared Aug 29, 1985
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
K852867 · CKA
Hi Chem, Inc.
Chemistry · 52d
Cleared Aug 29, 1985
PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET)
K852880 · DYB
Argon Medical Corp.
Cardiovascular · 51d
Cleared Aug 29, 1985
ORMCO TRANSMANDIBULAR IMPLANT
K852894 · MDL
Ormco Corp.
Dental · 51d
Cleared Aug 29, 1985
UNSCENTED ALWAYS PANTILINERS
K852985 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 45d
Cleared Aug 29, 1985
PORTABLE OXYGEN UNIT
K853004 · CAW
B & F Medical Products, Inc.
Anesthesiology · 44d
Cleared Aug 29, 1985
PRECEPT ERYTHROMYCIN
K853053 · LTW
Austin Biological Laboratories
Microbiology · 41d
Cleared Aug 29, 1985
MEDIX ELECTRONIC NEBULIZING SYSTEM
K853071 · CCQ
Medix Corp.
Anesthesiology · 37d
Cleared Aug 29, 1985
KOTEX SECURITY TUBE TAMPON
K853192 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 30d
Cleared Aug 29, 1985
PRECEPT AVGMENTIN
K853263 · LTW
Austin Biological Laboratories
Microbiology · 24d
Cleared Aug 29, 1985
DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR
K853336 · JSH
Hardy Media
Microbiology · 20d
Cleared Aug 29, 1985
6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG
K853342 · CAI
Sigma Medical, Inc.
Anesthesiology · 22d
Cleared Aug 29, 1985
3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W
K853343 · CAI
Sigma Medical, Inc.
Anesthesiology · 22d
Cleared Aug 29, 1985
4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT
K853344 · CAI
Sigma Medical, Inc.
Anesthesiology · 22d
Cleared Aug 29, 1985
SYNCHRONER TM (PROPOSED TRADENAME)
K853350 · CCQ
Fisons Corp.
Anesthesiology · 17d
Cleared Aug 29, 1985
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461 · GGP
American Dade
Hematology · 10d
Cleared Aug 29, 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462 · GGP
American Dade
Hematology · 10d
Cleared Aug 29, 1985
BBL CAMPY POUCH
K853534 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 6d
Cleared Aug 28, 1985
ADVANCED MEDICAL PRODUCTS MINI-M (TENS)
K852836 · GZJ
Advanced Medical Products, Inc.
Neurology · 57d
Cleared Aug 28, 1985
ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)
K852837 · GZJ
Advanced Medical Products, Inc.
Neurology · 57d
Cleared Aug 28, 1985
ADVANCED MEDICAL PRODUCTS MES TENS
K852838 · GZJ
Advanced Medical Products, Inc.
Neurology · 57d
Cleared Aug 28, 1985
THE DPC MONOCLONAL EIA TOTAL IGE KIT
K852878 · DGC
Diagnostic Products Corp.
Immunology · 50d
Cleared Aug 28, 1985
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
K853048 · DER
Photec Diagnostics, Inc.
Immunology · 40d
Cleared Aug 28, 1985
H-H VENTRICULAR CATHETERS & RESERVOIRS
K853361 · JXG
Holter-Hausner Intl.
Neurology · 16d