Ivy Biomedical Systems Inc

FDA Filings

This page includes the latest FDA filings for Ivy Biomedical Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1221108
• FEI Number: 1221108
• Name: IVY BIOMEDICAL SYSTEMS, INC.
• Owner & Operator: IVY BIOMEDICAL SYSTEMS, INC.
• Contact Address: 11 BUSINESS PARK DR. --; Branford CT 06405 US
• Official Correspondent:
  • Alejandra - Aceves
  • x-203-4814183-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11 BUSINESS PARK DR. ; Branford, CT 06405 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00816396022270 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3304-34-15	2023-06-19
GUDID 00816396023307 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band 3942-02-15	2023-06-16
GUDID 00816396023291 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band 3941-02-15	2023-06-16
GUDID 00816396023284 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band 3940-02-15	2023-06-16
GUDID 00816396023277 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band 3823-02-15	2023-06-16
GUDID 00816396023260 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band 3169-02-15	2023-06-16
GUDID 00816396023222 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3303-54-15	2023-06-16
GUDID 00816396023215 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3303-53-15	2023-06-16
GUDID 00816396023208 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3299-45-15	2023-06-16
GUDID 00816396023192 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-52-15	2023-06-16
GUDID 00816396023185 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3299-44-15	2023-06-16
GUDID 00816396023178 IVY BIOMEDICAL SYSTEMS, INC.	UPMM-X 4160-00-15	2023-06-16
GUDID 00816396023109 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3304-39-15	2023-06-16
GUDID 00816396023093 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3300-31-15	2023-06-16
GUDID 00816396023086 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800EP 3300-30-15	2023-06-16
GUDID 00816396023062 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800EP 3300-29-15	2023-06-16
GUDID 00816396022959 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-50-15	2023-06-16
GUDID 00816396022942 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3299-41-15	2023-06-16
GUDID 00816396022935 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800EP 3300-28-15	2023-06-16
GUDID 00816396022928 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3303-49-15	2023-06-16
GUDID 00816396022911 IVY BIOMEDICAL SYSTEMS, INC.	ECG Trunk Cable 590492	2023-06-16
GUDID 00816396022904 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3303-48-15	2023-06-16
GUDID 00816396022898 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3303-47-15	2023-06-16
GUDID 00816396022850 IVY BIOMEDICAL SYSTEMS, INC.	ECG Lead Wires 590490	2023-06-16
GUDID 00816396022843 IVY BIOMEDICAL SYSTEMS, INC.	ECG Lead Wires 590489	2023-06-16
GUDID 00816396022836 IVY BIOMEDICAL SYSTEMS, INC.	ECG Lead Wires 590491	2023-06-16
GUDID 00816396022829 IVY BIOMEDICAL SYSTEMS, INC.	ECG Patient Cable 590481	2023-06-16
GUDID 00816396022812 IVY BIOMEDICAL SYSTEMS, INC.	ECG Trunk Cable 590476	2023-06-16
GUDID 00816396022744 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3299-37-15	2023-06-16
GUDID 00816396022713 IVY BIOMEDICAL SYSTEMS, INC.	ECG Patient Cable 590478	2023-06-16
GUDID 00816396022706 IVY BIOMEDICAL SYSTEMS, INC.	ECG Patient Cable 590477	2023-06-16
GUDID 00816396022577 IVY BIOMEDICAL SYSTEMS, INC.	ECG Patient Cable 590480	2023-06-16
GUDID 00816396022560 IVY BIOMEDICAL SYSTEMS, INC.	ECG Patient Cable 590479	2023-06-16
GUDID 00816396022553 IVY BIOMEDICAL SYSTEMS, INC.	ECG Patient Cable 590482	2023-06-16
GUDID 00816396022287 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3304-35-15	2023-06-16
GUDID 00816396022263 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3304-33-15	2023-06-16
GUDID 00816396021563 IVY BIOMEDICAL SYSTEMS, INC.	UPMM-X 4161-00-01	2023-06-16
GUDID 00816396021495 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3303-51-15	2023-06-16
GUDID 00816396023079 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3299-42-15	2023-06-15
GUDID 00816396022881 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3299-40-15	2023-06-15
GUDID 00816396022874 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3299-39-15	2023-06-15
GUDID 00816396022867 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600EP 3299-38-15	2023-06-15
GUDID 00816396023253 IVY BIOMEDICAL SYSTEMS, INC.	WGS-100	2022-10-14
GUDID 00816396023246 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
GUDID 00816396023239 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
GUDID 00816396023161 IVY BIOMEDICAL SYSTEMS, INC.	WGS-100	2022-10-14
GUDID 00816396023154 IVY BIOMEDICAL SYSTEMS, INC.	WGS-100	2022-10-14
GUDID 00816396023147 IVY BIOMEDICAL SYSTEMS, INC.	WGS-100	2022-10-14
GUDID 00816396023130 IVY BIOMEDICAL SYSTEMS, INC.	WGS-100	2022-10-14
GUDID 00816396023123 IVY BIOMEDICAL SYSTEMS, INC.	WGS-100	2022-10-14
GUDID 00816396023116 IVY BIOMEDICAL SYSTEMS, INC.	WGS-100	2022-10-14
GUDID 00816396022805 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band	2022-10-14
GUDID 00816396022799 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band	2022-10-14
GUDID 00816396022782 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band	2022-10-14
GUDID 00816396022775 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band	2022-10-14
GUDID 00816396022768 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band	2022-10-14
GUDID 00816396022751 IVY BIOMEDICAL SYSTEMS, INC.	PPG Finger Band	2022-10-14
GUDID 00816396022737 IVY BIOMEDICAL SYSTEMS, INC.	MRI PPG Cable	2022-10-14
GUDID 00816396022720 IVY BIOMEDICAL SYSTEMS, INC.	MRI PPG Cable	2022-10-14
GUDID 00816396022638 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
GUDID 00816396022621 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
GUDID 00816396022614 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
GUDID 00816396022607 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
GUDID 00816396022591 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
GUDID 00816396022584 IVY BIOMEDICAL SYSTEMS, INC.	MRI ECG Cable	2022-10-14
PMN K202138 Ivy Biomedical Systems, Inc.	Cardiac Trigger Monitor	2021-05-14
PMN K192852 Ivy Biomedical Systems, Inc.	MRI ECG Patient Cable	2020-03-28
PMN K151781 | DRT IVY BIOMEDICAL SYSTEMS, INC.	Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor	2019-04-18
GUDID 00816396022478 IVY BIOMEDICAL SYSTEMS, INC.	ECG Lead Wires 590256	2018-10-15
GUDID 00816396022461 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3299-36-15	2018-10-15
GUDID 00816396022454 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-46-15	2018-10-15
GUDID 00816396022447 IVY BIOMEDICAL SYSTEMS, INC.	Model 7700 3603-04-15	2018-10-15
GUDID 00816396022430 IVY BIOMEDICAL SYSTEMS, INC.	Model 7700 3607-05-15	2018-10-15
GUDID 00816396022423 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3300-27-15	2018-10-15
GUDID 00816396022416 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3300-26-15	2018-10-15
GUDID 00816396022409 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3300-25-15	2018-10-15
GUDID 00816396022393 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3300-24-15	2018-10-15
GUDID 00816396022386 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3304-38-15	2018-10-15
GUDID 00816396022379 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3304-37-15	2018-10-15
GUDID 00816396022362 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3304-36-15	2018-10-15
GUDID 00816396022355 IVY BIOMEDICAL SYSTEMS, INC.	Model 7800 3300-23-15	2018-09-07
GUDID 00816396022348 IVY BIOMEDICAL SYSTEMS, INC.	ECG Lead Wires 590319	2018-09-07
GUDID 00816396022331 IVY BIOMEDICAL SYSTEMS, INC.	Model 7700 3607-04-15	2018-09-07
GUDID 00816396020191 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-24-15	2018-07-06
GUDID 00816396020184 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-23-15	2018-07-06
GUDID 00816396020177 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-22-15	2018-07-06
GUDID 00816396020160 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-21-15	2018-07-06
GUDID 00816396020153 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-20-15	2018-07-06
GUDID 00816396020146 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-19-15	2018-07-06
GUDID 00816396020139 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-16-15	2018-07-06
GUDID 00816396020122 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-15-15	2018-07-06
GUDID 00816396020115 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-14-15	2018-07-06
GUDID 00816396020108 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-12-15	2018-07-06
GUDID 00816396020092 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-10-15	2018-07-06
GUDID 00816396020085 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-09-15	2018-07-06
GUDID 00816396020078 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-08-15	2018-07-06
GUDID 00816396020061 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-07-15	2018-07-06
GUDID 00816396020054 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-06-15	2018-07-06
GUDID 00816396020047 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-05-15	2018-07-06
GUDID 00816396020030 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-04-15	2018-07-06
GUDID 00816396020023 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-03-15	2018-07-06
GUDID 00816396020016 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-02-15	2018-07-06
GUDID 00816396020009 IVY BIOMEDICAL SYSTEMS, INC.	Model 7600 3303-01-15	2018-07-06
PMN K171778 Ivy Biomedical Systems, Inc	MR Wireless Gating System, Model WGS-100	2018-03-14
PMN K170828 Ivy Biomedical Systems, Inc.	Cardiac Trigger Monitor	2017-05-17
IXO IVY BIOMEDICAL SYSTEMS, INC.	CTM-400	2016-11-09
PMN K151781 IVY BIOMEDICAL SYSTEMS INC.	Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor	2016-05-27
PMN K110987 | DRT IVY BIOMEDICAL SYSTEMS, INC.	7800	2012-03-05
PMN K110987 | DRT IVY BIOMEDICAL SYSTEMS, INC.	7700	2012-03-05
PMN K110987 | DRT IVY BIOMEDICAL SYSTEMS, INC.	7600	2012-03-05
PMN K110987 IVY BIOMEDICAL SYSTEMS, INC.	CARDIAC TRIGGER MONITOR	2011-07-22
PMN K091787 | DQA IVY BIOMEDICAL SYSTEMS, INC.	Model 6000	2010-10-07
PMN K091787 | CCK IVY BIOMEDICAL SYSTEMS, INC.	Model 6000	2010-10-07
PMN K091787 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 6000 TWO PARAMETER BEDSIDE MONITOR	2009-10-09
PMN K091985 | DRT IVY BIOMEDICAL SYSTEMS, INC.	UPMM	2009-08-21
PMN K083854 | DRT IVY BIOMEDICAL SYSTEMS, INC.	CTM300	2009-08-21
PMN K091985 IVY BIOMEDICAL SYSTEMS, INC.	UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE	2009-07-24
PMN K083854 IVY BIOMEDICAL SYSTEMS, INC.	CARDIAC TRIGGER, MODEL: CTM300	2009-02-13
PMN K964961 | CCK IVY BIOMEDICAL SYSTEMS, INC.	Model V-1200	2007-11-12
PMN K964961 | CCK IVY BIOMEDICAL SYSTEMS, INC.	Model 450C	2007-11-12
PMN K964961 | CCK IVY BIOMEDICAL SYSTEMS, INC.	Model 405T	2007-11-12
PMN K964961 | CCK IVY BIOMEDICAL SYSTEMS, INC.	Model 405C	2007-11-12
PMN K023616 | DRT IVY BIOMEDICAL SYSTEMS, INC.	Model 3200	2007-11-12
PMN K023616 | DRT IVY BIOMEDICAL SYSTEMS, INC.	Model 3150	2007-11-12
PMN K023616 | DRT IVY BIOMEDICAL SYSTEMS, INC.	Model 3100	2007-11-12
PMN K023616 | DRT IVY BIOMEDICAL SYSTEMS, INC.	Model 3050	2007-11-12
PMN K023616 | DRT IVY BIOMEDICAL SYSTEMS, INC.	Model 3000	2007-11-12
PMN K023616 IVY BIOMEDICAL SYSTEMS, INC.	PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)	2002-11-04
PMN K982255 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 2000 PULSE OXIMETER	1998-10-22
PMN K964961 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 405T WITH ETCO2 OPTION	1997-05-14
PMN K955546 IVY BIOMEDICAL SYSTEMS, INC.	PATIENT MONITOR MODEL 405P	1996-08-16
PMN K945099 IVY BIOMEDICAL SYSTEMS, INC.	PARAMETERS MONITORES	1995-07-13
PMN K912139 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 704	1992-03-25
PMN K904606 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 405	1991-03-01
PMN K901504 IVY BIOMEDICAL SYSTEMS, INC.	MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.	1990-08-23
PMN K884455 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 702 ECG/RESPIRATION/TEMPERATURE	1989-03-09
PMN K884096 IVY BIOMEDICAL SYSTEMS, INC.	PATIENT MONITOR MODEL 701	1989-02-23
PMN K884662 IVY BIOMEDICAL SYSTEMS, INC.	PATIENT MONITOR MODEL 703	1989-02-02
PMN K882118 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 700 PATIENT MONITOR	1988-08-02
PMN K882188 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR	1988-07-28
PMN K880066 IVY BIOMEDICAL SYSTEMS, INC.	MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR	1988-03-22
PMN K862647 IVY BIOMEDICAL SYSTEMS, INC.	PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403	1986-08-18
PMN K854840 IVY BIOMEDICAL SYSTEMS, INC.	PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A	1986-05-07

Related Finance Registrations

NCAGE Code	0HUY9	IVY BIOMEDICAL SYSTEMS, INC.
CAGE Code	0HUY9	IVY BIOMEDICAL SYSTEMS, INC.
DUNS	109132019	IVY BIOMEDICAL SYSTEMS, INC.
SEC	0000801022	IVY BIOMEDICAL SYSTEMS INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018122928860	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	CONNECTION BRACKET .	2 CRT
2018122425688	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	CARBON FIBER COVER	1 PKG
2018112817409	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	CONNECTION BRACKET .	2 CRT
2018103114085	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	CARBON FIBER COVER	1 CTN
2018102723073	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	CARBON FIBER COVER	1 CTN
201810205569	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	CARBON FIBER COVER	1 PKG
2018101818912	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	CONNECTION BRACKET .	1 CRT
2018100823343	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	CARBON FIBER COVER	1 PKG