FDA Device Entity Profile: Datascope Corp.

Known Identifiers & Locations

FEI Numbers 1000222374, 2221819, 3001418283, 3007965489

Owner Operator Numbers 2221819

Locations Covered FAIRFIELD, NJ, US; MAHWAH, NJ, US; Wayne, NJ, US

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2248146	Datascope Corp.	FAIRFIELD, NJ, US	Complaint File Establishment per 21 CFR 820.198	View Details
2249723	Datascope Corp.	MAHWAH, NJ, US	Manufacture Medical Device	View Details
3007965489	Datascope Corp	Wayne, NJ, US	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K903893	DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL	1990-10-19	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0018-05	Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Reason: Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.	2004-09-24	Terminated	View Details

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