Medical Device Manufacturer · US , Indianapolis , IN

Promedic, Inc.

16 submissions · 14 cleared · Since 1995
16
Total
14
Cleared
0
Denied

Promedic, Inc. — FDA 510(k) Submissions

Promedic, Inc. has submitted 16 FDA 510(k) premarket notifications since 1995, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tubes, Gastrointestinal (and Accessories), Nebulizer (direct Patient Interface), Analyzer, Gas, Carbon-dioxide, Gaseous-phase, Ventilator, Emergency, Manual (resuscitator), Pump, Infusion . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
EUM 100PRO
K131889 · OSP Uterine Electromyographic... · Obstetrics & Gynecology
Apr 2014 302d
CLEARPATH 24
K112318 · OCX Endoscopic... · Gastroenterology & Urology
Jun 2012 323d
NON-IV ADAPTER FOR INFANT NG TUBE
K072756 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Dec 2007 83d
BABYAIR
K060497 · CAF Nebulizer (direct Patient... · Anesthesiology
Jul 2006 137d
REVJET TURBO
K060842 · CAF Nebulizer (direct Patient... · Anesthesiology
Jun 2006 85d
PEDIATRIC FEEDING TUBE
K052903 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Nov 2005 26d
URINARY CATHETERS
K031409 · GBM Catheter, Urethral · Gastroenterology & Urology
Jun 2003 43d
FENESTRATED INFUSION CATHETER
K024190 · FRN Pump, Infusion · General Hospital
Mar 2003 88d
GAS SAMPLING LINES
K023579 · CCK Analyzer, Gas,... · Anesthesiology
Jan 2003 96d
INFANT FEEDING TUBES
K020005 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jul 2002 195d
FILTER
K970102 · CAH Filter, Bacterial,... · General Hospital
Jun 1997 162d
DATEX ENGSTOM MANUAL RESUSCITATOR
K970991 · BTM Ventilator, Emergency,... · Anesthesiology
Jun 1997 89d
BURLEW INFANT HOOD
K962182 · FOG Hood, Oxygen, Infant · Anesthesiology
Jul 1996 39d
BUONAFEDE PNEUMATIC SLEEVE
K954201 · KCY Tourniquet, Pneumatic · General & Plastic Surgery
Nov 1995 64d
PRESSURIZER
K951988 · KZD Infusor, Pressure, For... · General Hospital
Jun 1995 48d
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
K951043 · BSJ Mask, Gas, Anesthetic · Anesthesiology
Jun 1995 92d
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