Penlon L T D

FDA Filings

This page includes the latest FDA filings for Penlon L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9610531
FEI Number3002807907
NameJerry Andexler
Owner & OperatorPENLON LTD.
Contact AddressABINGDON SCIENCE PARK BARTON LANE
ABINGDON GB-NOTA OX14 3NB GB
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2601 Stanley Gault PKWY Suite 101, Louisville, KY US
Louisville, KY 40223 US
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Foreign Private Label Distributor

FDA Filings

Device
Company
DeviceDate
PENLON LTD
 Penlon 549092023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 Penlon 2023-06-29
PENLON LTD
 AnaVue 4000 Patient Monitor 50052402020-02-13
Jerry Andexler [PENLON LTD.]
AnaVue 40002019-10-25
PENLON LTD
 AV-S MRI Ventilator 2018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Penlon 534502018-07-06
PENLON LTD
 Key Filler Bottle Adaptor MRI 2018-07-06
PENLON LTD
 Penlon 534542018-07-06
PENLON LTD
 Penlon 534532018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Prima 451 2018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Penlon 2018-07-06
PENLON LTD
 Penlon 9910-2442018-03-29
PENLON LTD
 Penlon 9510-026-4M2018-03-29
PENLON LTD
 Penlon 3101042018-03-29
PENLON LTD
 SC760 MRI Suction Controller 2m hose 2018-03-29
PENLON LTD
 Penlon 9510-0262018-03-29
PENLON LTD
 Penlon 50074942018-03-29
PENLON LTD
 SC760 MRI Suction Controller 4m hose 2018-03-29
PENLON LTD
 Penlon 3101022018-03-29
PENLON LTD
 Penlon 310105-0.5M2018-03-29
PENLON LTD
 Penlon 3101052018-03-29
PENLON LTD
 Penlon 3101062018-03-29
PENLON LTD
 Penlon 3100232018-03-29
PENLON LTD
 Penlon 4840-1132018-03-29
PENLON LTD
 Penlon 9510-0292018-03-29
PENLON LTD
 Penlon 3101072018-03-29
PENLON LTD
 Penlon 3101012018-03-29
PENLON LTD
 Penlon 310101-DIN2018-03-29
PENLON LTD
 Penlon 9510-0252018-03-29
PENLON LTD
 Penlon 3100052018-03-29
PENLON LTD
 Penlon 4840-1122018-03-29
PENLON LTD
 A200SP Absorber MRI 2018-03-29
PENLON LTD
 Penlon 2018-03-29
PENLON LTD
 Penlon 2018-03-29
PENLON LTD
 Penlon 2018-03-29
Jerry Andexler [PENLON LTD.]
Oriel 4000 Patient Monitor2012-07-13
Jerry Andexler [PENLON LTD.]
Oriel 3000 Patient Monitor2012-07-13
Jerry Andexler [PENLON LTD.]
Associated modules e.g. Anaesthetic Gas Module2012-07-13
Jerry Andexler [PENLON LTD.]
Quik-Fil Vaporizer Keyed Filler2007-11-19
Jerry Andexler [PENLON LTD.]
Nuffield 200 MRI Ventilator2007-11-19
Jerry Andexler [PENLON LTD.]
N200 Ventilator2007-11-19
Jerry Andexler [PENLON LTD.]
Prima 4602007-11-19
Jerry Andexler [PENLON LTD.]
Prima 451 MRI2007-11-19
Jerry Andexler [PENLON LTD.]
Prima 4502007-11-19
Jerry Andexler [PENLON LTD.]
Prima 4452007-11-19
Jerry Andexler [PENLON LTD.]
Prima 4402007-11-19
Jerry Andexler [PENLON LTD.]
Keyed Filler Bottle Adaptor2007-11-19
Jerry Andexler [PENLON LTD.]
Keyed Filler Bottle Adaptor MRI2007-11-19
Jerry Andexler [PENLON LTD.]
AV-S MRI Anaesthesia Ventilator2007-11-19
Jerry Andexler [PENLON LTD.]
AV-S Anaesthesia Ventilator2007-11-19
Jerry Andexler [PENLON LTD.]
Sigma Delta Vaporizer2007-11-19
Jerry Andexler [PENLON LTD.]
Sigma Delta MRI Vaporizer2007-11-19
PENLON LTD.
PRIMA ANAESTHESIA MACHINE2006-07-28
PENLON LIMITED
SIGMA ALPHA VAPORIZER2006-05-10
PENLON LIMITED
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 534542006-03-03
Jerry Andexler [PENLON LTD.]
OXYGEN FLOWMETER2006-02-06
PENLON LIMITED
AV-S ANAESTHESIA VENTILATOR2005-09-23
Jerry Andexler [PENLON LTD.]
A200SP2005-06-28
Jerry Andexler [PENLON LTD.]
A200SP MRI2005-06-28
PENLON LTD.
DELTA T2004-08-09
Jerry Andexler [PENLON LTD.]
SUCTION SYSTEMS2003-03-17
Jerry Andexler [PENLON LTD.]
SUCTION CONTROLLERS2003-03-17
Jerry Andexler [PENLON LTD.]
SC760 Suction Controllers2003-03-17
Jerry Andexler [PENLON LTD.]
SC760 MRI Suction Controller 4m hose2003-03-17
Jerry Andexler [PENLON LTD.]
SC760 MRI Suction Controller 2m hose2003-03-17
Jerry Andexler [PENLON LTD.]
"East Range" Suction Controllers2003-03-17
Jerry Andexler [PENLON LTD.]
Penlon Premier Laryngoscope Blades, Handles & Bulbs2002-04-24
Jerry Andexler [PENLON LTD.]
Penlon Diamond MRI Laryngoscope Blades, Handles & Bulbs2002-04-24
Jerry Andexler [PENLON LTD.]
Penlon Diamond Laryngoscope Blades, Handles & Bulbs2002-04-24
Jerry Andexler [PENLON LTD.]
Penlon Crystal Metal Disposable Laryngoscope Handles & Bulbs2002-04-24
Jerry Andexler [PENLON LTD.]
Penlon Conventional Laryngoscope Blades, Handles & Bulbs2002-04-24
Jerry Andexler [PENLON LTD.]
CIRCUIT2002-04-24
Jerry Andexler [PENLON LTD.]
BREATHING (MULTIPLE BRANDS)2002-04-24
PENLON LTD.
PRIMA OXYGEN MONITOR2001-07-23
PENLON LTD.
AV 800 VENTILATOR2001-07-23
PENLON LTD.
SIGMA DELTA2001-06-08
PENLON LTD.
QUIK-FIL VAPORIZER KEYED FILLER1996-07-16
PENLON LTD.
PPV VAPORIZER (MODIFICATION)1996-04-02
PENLON LTD.
CLM LARYNGOSCOPE1995-10-06
PENLON LTD.
SIGMA ELITE1995-02-03

Related Finance Registrations
NCAGE CodeK4619PENLON LTD
CAGE CodeK4619PENLON LTD
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091968099London,United Kingdom -> New York, New YorkANAESTHESIA MACHINE HS CODE 9018902 PCS
201902016585Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT8 PCS
2019010457706Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT8 PCS
2018092840496London,United Kingdom -> Charleston, South CarolinaMEDICAL EQUIPMENT2 CAS
2018092066642London,United Kingdom -> Charleston, South CarolinaMEDICAL EQUIPMENT2 CAS
2018012248793London,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT8 PCS
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