BIODEX MEDICAL SYSTEMS, INC.

Matched from indexed company URL: BIODEX CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2431314	2431314	BIODEX MEDICAL SYSTEMS, INC.	1	N	2020-04-25	20 Ramsey Rd Shirley NY US 11967

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
7055	1474772080	K904717	MICRO-VENT NEBULIZER SYSTEM	CAF	1991-04-01
7055	1433327095	K901476	MODIFIED ENTRAPPING FILTER	CAH	1990-05-01
7055	1191588785	K884312	ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270	KPT	1989-02-16
7055	1915494690	K871868	VENTI-SCAN II	IYT	1988-04-11
7055	1393316064	K800023	LUNG AEROSOL UNIT	CAF	1985-01-01
7055	1821229810	K090296	ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336	KPT	2009-02-19
7055	1622428917	K063666	SHARPS CONTAINER, MODEL 039-413	MMK	2007-01-25
7055	1007765961
7055	1015589080
7055	1017465166
7055	1168118915
7055	1216530802
7055	1364787325
7055	1427078128
7055	1463398899
7055	1525402132
7055	1568189522
7055	1690826309
7055	1750528104
7055	1771180642
7055	1833243562
7055	1911076357
7055	1926229100
7055	1928147161
7055	1945679650
7055	1951561361
7055	2007706668
7055	2026850170

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KPT	2	2009-02-19
CAF	2	1991-04-01
MMK	1	2007-01-25
CAH	1	1990-05-01
IYT	1	1988-04-11

PMN#

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

2009-02-19

BIODEX MEDICAL SYSTEMS, INC.

SHARPS CONTAINER, MODEL 039-413

2007-01-25

BIODEX MEDICAL SYSTEMS, INC.

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP

1995-11-16

BIODEX MEDICAL SYSTEMS, INC.

ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650

1995-04-03

BIODEX MEDICAL SYSTEMS, INC.

STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302

1995-03-10

BIODEX MEDICAL SYSTEMS, INC.

COMPEX 2

1994-12-28

BIODEX MEDICAL SYSTEMS, INC.

LOWER BODY CYCLES

1994-09-16

BIODEX MEDICAL SYSTEMS, INC.

SEMI-RECUMBENT CYCLES

1994-09-16

BIODEX MEDICAL SYSTEMS, INC.

UPPER BODY CYCLES (110 VOLT)/(220 VOLT)

1994-09-16

BIODEX MEDICAL SYSTEMS, INC.

BIODEX SYSTEM 2 AUTOPROGRAM

1992-01-13

BIODEX CORP.

BIODEX SYSTEM 2 AUTOPROGRAM

1992-01-09

BIODEX CORP.

BIODEX SYSTEM 2,MODEL S2-S

1991-10-03

BIODEX CORP.

BIODEX,MODEL B-2000

1991-10-03

BIODEX CORP.

BIODEX LIFT SIMULATOR

1990-07-24

BIODEX CORP.

BIODEX BACK SYSTEM ATTACHMENT

1990-02-26

BIODEX CORP.

BIODEX SYSTEM

1986-04-18

BIODEX CORP.

GUDID#

Neck Phantom - Neck Phantom, Thyroid Uptake

BIODEX MEDICAL SYSTEMS, INC.

2018-02-15

SHARPS CONTAINER SHIELD - "Shield, Sharps, Container, Dual, .125"" Lead "

BIODEX MEDICAL SYSTEMS, INC.

2019-05-31

Pro-Tec Pet Syringe Shield - Pro-Tec Pet Syringe Shield, Tungsten, Without Lead Glass Window 10cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec Pet Syringe Shield - Pro-Tec Pet, Syringe Shield, Tungsten, Without Lead Glass Window 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Bar Phantom - "Bar Phantom, Symbia, 21"" X 16"""

BIODEX MEDICAL SYSTEMS, INC.

2018-02-15

Pet Dose Drawing Syringe Shield - Pet Dose Drawing Syringe Shield, Tungsten 3cc, with Lead Glass Window

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec Pet Syringe Shield - Pro-Tec Pet Syringe Shield, Tungsten, Without Lead Glass Window 3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pet Dose Drawing Syringe Shield - Pet Dose Drawing Syringe Shield, Tungsten 5cc, with Lead Glass Window

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec Pet Syringe Shield - Pro-Tec Pet Syringe Shield, Tungsten Without Lead Glass Window, 1cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec Pet Syringe Shield - Pro-Tec Pet, Syringe Shield, Tungsten With Lead Glass Window, 10cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec Pet Syringe Shield - Pro-Tec Pet Syringe Shield, Tungsten, With Lead Glass Window, 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec Pet Syringe Shield - Pro-Tec Pet, Syringe Shield, Tungsten with Lead Glass Window, 3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Pet / MR Pro-Tec, Syringe Shield - Pet / MR Pro-Tec, Syringe Shield, Tungsten with Lead Glass Window, 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Pet / MR Pro-Tec, Syringe Shield - Pet / MR Pro-Tec, Syringe Shield, Tungsten with Lead Glass Window, 3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-13

BETA, Syringe Shield - BETA, Lead Encapsulated Syringe Shield, 10cc

BIODEX MEDICAL SYSTEMS, INC.

2017-11-22

BETA, Syringe Shield - BETA, Lead Encapsulated Syringe Shield, 1cc

BIODEX MEDICAL SYSTEMS, INC.

2017-11-22

Bar Phantom - Bar Phantom, Cardiac, High Resolution

BIODEX MEDICAL SYSTEMS, INC.

2018-02-15

Z-Pet, Syringe Shield - Z-Pet, Syringe Shield, Tungsten, with no Glass Window, 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-13

Bar Phantom - Bar Phantom, Rectangular

BIODEX MEDICAL SYSTEMS, INC.

2018-02-15

Pro-Tec II, Syringe Shield - Pro-Tec II, Syringe Shield, Tungsten, with no Glass Window, 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-13

Pro-Tec II Syringe Shield - Pro-Tec II Syringe Shield, Tungsten 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-19

Bar Phantom - Bar Phantom, GE

BIODEX MEDICAL SYSTEMS, INC.

2018-02-15

Pro-Tec II, Syringe Shield - Pro-Tec II, Syringe Shield, Tungsten, with no Glass Window, 3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-13

Pro-Tec II Syringe Shield - Pro-Tec II Syringe Shield, Tungsten,3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-28

Pro-Tec III Syringe Shield - Pro-Tec III Syringe Shield, Tungsten 2.5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec III Syringe Shield - Pro-Tec III Syringe Shield, Tungsten 10cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec III Syringe Shield - Pro-Tec III Syringe Shield, Tungsten 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec III Syringe Shield - Pro-Tec III Syringe Shield, Tungsten 3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec III Syringe Shield - Pro-Tec III Syringe Shield, Tungsten 1cc (Press Fit)

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pro-Tec III Syringe Shield - Pro-Tec III Syringe Shield, Tungsten 1cc (BD Luer Lock)

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

Pet Gaard Lock, Syringe Shield - Pet Gaard Lock, Syringe Shield, Tungsten with Lead Glass Window, 10cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Pet Gaard Lock Syringe Shield - Pet Gaard Lock, Syringe Shield, Tungsten with Lead Glass Window, 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Pet Gaard Lock, Syringe Shields - Pet Gaard Lock Syringe Shield, Tungsten with Lead Glass Window, 3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-13

Pet Gaard Lock, Syringe Shield - Pet Gaard Lock, Syringe Shield, Tungsten without Lead Glass Window, 10cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-13

Pet Gaard Lock, Syringe Shield - Pet Gaard Lock, Syringe Shield, Tungsten without Lead Glass Window 5cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Pet Gaard Lock, Syringe Shield - Pet Gaard Lock, Syringe Shield, Tungsten without Lead Glass Window, 3cc

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Dose Drawing, Syringe Shield - Dose Drawing, Syringe Shield, Lead Glass, 10/12cc, accommodates Luer and Non-Luer Lock Syringes. Replaceable Lead Glass.

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Dose Drawing, Syringe Shield - Dose Drawing, Syringe Shield, Lead Glass, 5/6cc, accommodates Luer and Non-Luer Lock Syringes. Replaceable Lead Glass

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Dose Drawing, Syringe Shield - Dose Drawing, Syringe Shield, Lead Glass, 3cc, accommodates Luer and Non-Luer Lock Syringes. Replaceable Lead Glass.

BIODEX MEDICAL SYSTEMS, INC.

2017-10-06

Pro-Tec IV Syringe Shield - Pro-Tec IV Syringe Shield, Lead Glass 10cc

BIODEX MEDICAL SYSTEMS, INC.

2017-09-29

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