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 Number: 9610531
• FEI Number: 3002807907
• Name: Jerry Andexler
• Owner & Operator: PENLON LTD.
• Contact Address: ABINGDON SCIENCE PARK BARTON LANE; ABINGDON GB-NOTA OX14 3NB GB
• US Agent:
  • Jerry Andexler
  • DRE, INC DBA Avante Health Solutions
  • 502 2444444
  • jerry.andexler@avantehs.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2601 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	Device	Date
GUDID 05051977003827 PENLON LTD	Penlon 408001022	2024-12-16
GUDID 05051977003810 PENLON LTD	Penlon 408001021	2024-12-16
GUDID 05051977003803 PENLON LTD	Penlon 408001020	2024-12-16
GUDID 05051977003773 PENLON LTD	Penlon 408001025	2024-12-16
GUDID 05051977003766 PENLON LTD	Penlon 408001004	2024-12-16
GUDID 05051977003759 PENLON LTD	Penlon 408001019	2024-12-16
GUDID 05051977003742 PENLON LTD	Penlon 408001018	2024-12-16
GUDID 05051977003735 PENLON LTD	Penlon 408001017	2024-12-16
GUDID 05051977003728 PENLON LTD	Penlon 408001016	2024-12-16
GUDID 05051977003711 PENLON LTD	Penlon 408001015	2024-12-16
GUDID 05051977003704 PENLON LTD	Penlon 408001014	2024-12-16
GUDID 05051977003698 PENLON LTD	Penlon 408001013	2024-12-16
GUDID 05051977003681 PENLON LTD	Penlon 408001012	2024-12-16
GUDID 05051977003674 PENLON LTD	Penlon 408001011	2024-12-16
GUDID 05051977003667 PENLON LTD	Penlon 408001010	2024-12-16
GUDID 05051977003650 PENLON LTD	Penlon 408001009	2024-12-16
GUDID 05051977003643 PENLON LTD	Penlon 408001008	2024-12-16
GUDID 05051977003636 PENLON LTD	Penlon 408001007	2024-12-16
GUDID 05051977003629 PENLON LTD	Penlon 408001006	2024-12-16
GUDID 05051977003612 PENLON LTD	Penlon 408001005	2024-12-16
GUDID 05051977003605 PENLON LTD	Penlon 408001002	2024-12-16
GUDID 05051977003599 PENLON LTD	Penlon 408001001	2024-12-16
GUDID 05051977002042 PENLON LTD	Penlon 410502I-M	2024-12-16
GUDID 05051977002035 PENLON LTD	Penlon 410502S-M	2024-12-16
GUDID 05051977002028 PENLON LTD	Penlon 410502S	2024-12-16
GUDID 05051977002011 PENLON LTD	Penlon 410502I	2024-12-16
GUDID 05051977001465 PENLON LTD	Penlon 410502H	2024-12-16
GUDID 05051977000857 PENLON LTD	Penlon 5011305	2024-12-16
GUDID 05051977001595 PENLON LTD	Penlon 54909	2023-06-29
GUDID 05051977000819 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000802 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000796 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000789 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000772 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000765 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000758 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000635 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000628 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000611 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000604 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000598 PENLON LTD	Penlon	2023-06-29
GUDID 05051977000666 PENLON LTD	AnaVue 4000 Patient Monitor 5005240	2020-02-13
PMN K131898 | MWI Jerry Andexler [PENLON LTD.]	AnaVue 4000	2019-10-25
GUDID 05051977000567 PENLON LTD	AV-S MRI Ventilator	2018-07-06
GUDID 05051977000536 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000444 PENLON LTD	Penlon 53450	2018-07-06
GUDID 05051977000314 PENLON LTD	Key Filler Bottle Adaptor MRI	2018-07-06
GUDID 05051977000260 PENLON LTD	Penlon 53454	2018-07-06
GUDID 05051977000222 PENLON LTD	Penlon 53453	2018-07-06
GUDID 05051977000116 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000079 PENLON LTD	Prima 451	2018-07-06
GUDID 05051977000055 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000048 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000031 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000024 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000017 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000000 PENLON LTD	Penlon	2018-07-06
GUDID 05051977000390 PENLON LTD	Penlon 9910-244	2018-03-29
GUDID 05051977000383 PENLON LTD	Penlon 9510-026-4M	2018-03-29
GUDID 05051977000376 PENLON LTD	Penlon 310104	2018-03-29
GUDID 05051977000369 PENLON LTD	SC760 MRI Suction Controller 2m hose	2018-03-29
GUDID 05051977000352 PENLON LTD	Penlon 9510-026	2018-03-29
GUDID 05051977000345 PENLON LTD	Penlon 5007494	2018-03-29
GUDID 05051977000338 PENLON LTD	SC760 MRI Suction Controller 4m hose	2018-03-29
GUDID 05051977000321 PENLON LTD	Penlon 310102	2018-03-29
GUDID 05051977000307 PENLON LTD	Penlon 310105-0.5M	2018-03-29
GUDID 05051977000291 PENLON LTD	Penlon 310105	2018-03-29
GUDID 05051977000277 PENLON LTD	Penlon 310106	2018-03-29
GUDID 05051977000215 PENLON LTD	Penlon 310023	2018-03-29
GUDID 05051977000208 PENLON LTD	Penlon 4840-113	2018-03-29
GUDID 05051977000192 PENLON LTD	Penlon 9510-029	2018-03-29
GUDID 05051977000185 PENLON LTD	Penlon 310107	2018-03-29
GUDID 05051977000178 PENLON LTD	Penlon 310101	2018-03-29
GUDID 05051977000154 PENLON LTD	Penlon 310101-DIN	2018-03-29
GUDID 05051977000147 PENLON LTD	Penlon 9510-025	2018-03-29
GUDID 05051977000130 PENLON LTD	Penlon 310005	2018-03-29
GUDID 05051977000123 PENLON LTD	Penlon 4840-112	2018-03-29
GUDID 05051977000109 PENLON LTD	A200SP Absorber MRI	2018-03-29
GUDID 05051977000093 PENLON LTD	Penlon	2018-03-29
GUDID 05051977000086 PENLON LTD	Penlon	2018-03-29
GUDID 05051977000062 PENLON LTD	Penlon	2018-03-29
PMN K120193 | MWI Jerry Andexler [PENLON LTD.]	Oriel 4000 Patient Monitor	2012-07-13
PMN K120193 | MWI Jerry Andexler [PENLON LTD.]	Oriel 3000 Patient Monitor	2012-07-13
PMN K120193 | MWI Jerry Andexler [PENLON LTD.]	Associated modules e.g. Anaesthetic Gas Module	2012-07-13
PMN K961468 | CAD Jerry Andexler [PENLON LTD.]	Quik-Fil Vaporizer Keyed Filler	2007-11-19
PMN K803052 | BSZ Jerry Andexler [PENLON LTD.]	Nuffield 200 MRI Ventilator	2007-11-19
PMN K803052 | BSZ Jerry Andexler [PENLON LTD.]	N200 Ventilator	2007-11-19
PMN K061102 | BSZ Jerry Andexler [PENLON LTD.]	Prima 460	2007-11-19
PMN K061102 | BSZ Jerry Andexler [PENLON LTD.]	Prima 451 MRI	2007-11-19
PMN K061102 | BSZ Jerry Andexler [PENLON LTD.]	Prima 450	2007-11-19
PMN K061102 | BSZ Jerry Andexler [PENLON LTD.]	Prima 445	2007-11-19
PMN K061102 | BSZ Jerry Andexler [PENLON LTD.]	Prima 440	2007-11-19
PMN K053564 | CAD Jerry Andexler [PENLON LTD.]	Keyed Filler Bottle Adaptor	2007-11-19
PMN K053564 | CAD Jerry Andexler [PENLON LTD.]	Keyed Filler Bottle Adaptor MRI	2007-11-19
PMN K051222 | CBK Jerry Andexler [PENLON LTD.]	AV-S MRI Anaesthesia Ventilator	2007-11-19
PMN K051222 | CBK Jerry Andexler [PENLON LTD.]	AV-S Anaesthesia Ventilator	2007-11-19
PMN K002343 | CAD Jerry Andexler [PENLON LTD.]	Sigma Delta Vaporizer	2007-11-19
PMN K002343 | CAD Jerry Andexler [PENLON LTD.]	Sigma Delta MRI Vaporizer	2007-11-19
PMN K061102 PENLON LTD.	PRIMA ANAESTHESIA MACHINE	2006-07-28
PMN K060331 PENLON LIMITED	SIGMA ALPHA VAPORIZER	2006-05-10
PMN K053564 PENLON LIMITED	KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454	2006-03-03
BYM Jerry Andexler [PENLON LTD.]	OXYGEN FLOWMETER	2006-02-06
PMN K051222 PENLON LIMITED	AV-S ANAESTHESIA VENTILATOR	2005-09-23
BSF Jerry Andexler [PENLON LTD.]	A200SP	2005-06-28
BSF Jerry Andexler [PENLON LTD.]	A200SP MRI	2005-06-28
PMN K041076 PENLON LTD.	DELTA T	2004-08-09
GCX Jerry Andexler [PENLON LTD.]	SUCTION SYSTEMS	2003-03-17
GCX Jerry Andexler [PENLON LTD.]	SUCTION CONTROLLERS	2003-03-17
GCX Jerry Andexler [PENLON LTD.]	SC760 Suction Controllers	2003-03-17
GCX Jerry Andexler [PENLON LTD.]	SC760 MRI Suction Controller 4m hose	2003-03-17
GCX Jerry Andexler [PENLON LTD.]	SC760 MRI Suction Controller 2m hose	2003-03-17
GCX Jerry Andexler [PENLON LTD.]	"East Range" Suction Controllers	2003-03-17
CCW Jerry Andexler [PENLON LTD.]	Penlon Premier Laryngoscope Blades, Handles & Bulbs	2002-04-24
CCW Jerry Andexler [PENLON LTD.]	Penlon Diamond MRI Laryngoscope Blades, Handles & Bulbs	2002-04-24
CCW Jerry Andexler [PENLON LTD.]	Penlon Diamond Laryngoscope Blades, Handles & Bulbs	2002-04-24
CCW Jerry Andexler [PENLON LTD.]	Penlon Crystal Metal Disposable Laryngoscope Handles & Bulbs	2002-04-24
CCW Jerry Andexler [PENLON LTD.]	Penlon Conventional Laryngoscope Blades, Handles & Bulbs	2002-04-24
CAI Jerry Andexler [PENLON LTD.]	CIRCUIT	2002-04-24
CAI Jerry Andexler [PENLON LTD.]	BREATHING (MULTIPLE BRANDS)	2002-04-24
PMN K010318 PENLON LTD.	PRIMA OXYGEN MONITOR	2001-07-23
PMN K010317 PENLON LTD.	AV 800 VENTILATOR	2001-07-23
PMN K002343 PENLON LTD.	SIGMA DELTA	2001-06-08
PMN K961468 PENLON LTD.	QUIK-FIL VAPORIZER KEYED FILLER	1996-07-16
PMN K960944 PENLON LTD.	PPV VAPORIZER (MODIFICATION)	1996-04-02
PMN K953179 PENLON LTD.	CLM LARYNGOSCOPE	1995-10-06
PMN K942545 PENLON LTD.	SIGMA ELITE	1995-02-03

Related Finance Registrations

NCAGE Code	K4619	PENLON LTD
CAGE Code	K4619	PENLON LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091968099	London,United Kingdom -> New York, New York	ANAESTHESIA MACHINE HS CODE 901890	2 PCS
201902016585	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	8 PCS
2019010457706	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	8 PCS
2018092840496	London,United Kingdom -> Charleston, South Carolina	MEDICAL EQUIPMENT	2 CAS
2018092066642	London,United Kingdom -> Charleston, South Carolina	MEDICAL EQUIPMENT	2 CAS
2018012248793	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	8 PCS