Medical Device Manufacturer · US , St Louis , MO

Mallinckrodt Medical

43 submissions · 42 cleared · Since 1990
43
Total
42
Cleared
0
Denied

Mallinckrodt Medical — FDA 510(k) Submissions

Mallinckrodt Medical has submitted 43 FDA 510(k) premarket notifications since 1990, of which 42 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tube Tracheostomy And Tube Cuff, Catheter, Percutaneous, Condenser, Heat And Moisture (artificial Nose), Filter, Bacterial, Breathing-circuit, Tube, Tracheal (w/wo Connector) . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Oct 2008 30d
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416 · JOH Tube Tracheostomy And... · Anesthesiology
Jun 2005 15d
HI-CARE CLOSED SUCTION SYSTEM
K972258 · BSY Catheters, Suction,... · Anesthesiology
Dec 1997 195d
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267 · JOH Tube Tracheostomy And... · Anesthesiology
Sep 1997 174d
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732 · JOH Tube Tracheostomy And... · Anesthesiology
Jun 1997 282d
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721 · CAE Airway, Oropharyngeal,... · Anesthesiology
Mar 1997 466d
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Mar 1997 87d
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · CAH Filter, Bacterial,... · General Hospital
Nov 1996 182d
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173 · JOH Tube Tracheostomy And... · Anesthesiology
Oct 1996 121d
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
K955680 · JOH Tube Tracheostomy And... · Anesthesiology
Mar 1996 90d
MALLINCKRODT SHILEY 15MM CAP
K954749 · JOH Tube Tracheostomy And... · Anesthesiology
Jan 1996 100d
UTK-DTE AUTILARY SHIELD
K954146 · KPY Shield, Protective,... · Radiology
Dec 1995 92d
GUEDEL AIRWAY
K953400 · CAE Airway, Oropharyngeal,... · Anesthesiology
Oct 1995 96d
ANESTHESIA FACE MASK
K953295 · BSJ Mask, Gas, Anesthetic · Anesthesiology
Aug 1995 28d
FLEXLIFE
K952036 · BYD Condenser, Heat And... · Anesthesiology
Jun 1995 38d
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513 · JOH Tube Tracheostomy And... · Anesthesiology
Jan 1995 65d
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K943739 · DQO Catheter, Intravascular,... · Cardiovascular
Nov 1994 105d
WARMTOUCH PLASTIC WARMING COVER
K943276 · DWJ System, Thermal Regulating · Cardiovascular
Sep 1994 74d
SPIROBAC ADAPTERS
K944124 · CAH Filter, Bacterial,... · General Hospital
Sep 1994 16d
AIRWAY CONNECTOR WITH FLEX TUBE
K942392 · BZA Connector, Airway... · Anesthesiology
Aug 1994 95d
HYGROLIFE
K942794 · BYD Condenser, Heat And... · Anesthesiology
Aug 1994 69d
STERIVENT AND STERIVENT S
K941676 · CAH Filter, Bacterial,... · General Hospital
May 1994 45d
BARRIERBAC AND BARRIERBAC S
K941536 · CAH Filter, Bacterial,... · General Hospital
Apr 1994 20d
HYGROSTER
K941585 · BYD Condenser, Heat And... · Anesthesiology
Apr 1994 19d
HYGROBAC,S HYGROBOY AND HYGROBABY
K941381 · CAH Filter, Bacterial,... · General Hospital
Apr 1994 24d
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