Bio Detek Inc

FDA Filings

This page includes the latest FDA filings for Bio Detek 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: 1218058
• FEI Number: 1218058
• Name: BIO-DETEK, INC.
• Owner & Operator: ZOLL Medical Corporation
• Contact Address: 269 & 271 Mill Road --; Chelmsford MA 01824 US
• Official Correspondent:
  • Paul - Dias
  • x-978-4219413-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 525 Narragansett Park Dr ; PAWTUCKET, RI 02861 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00847946023041 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946023034 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946022167 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946022136 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946022105 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946022099 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946022082 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946022068 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946022044 BIO-DETEK INCORPORATED	ECG	2021-03-18
GUDID 00847946028381 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2020-12-01
GUDID 10847946023215 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2020-10-30
GUDID 00847946027131 BIO-DETEK INCORPORATED	ECG	2020-04-03
GUDID 00847946027124 BIO-DETEK INCORPORATED	ECG	2020-04-03
GUDID 00847946027117 BIO-DETEK INCORPORATED	ECG	2020-04-03
GUDID 00847946027094 BIO-DETEK INCORPORATED	ECG	2020-04-03
GUDID 00847946027087 BIO-DETEK INCORPORATED	ECG	2020-04-03
GUDID 00847946027179 BIO-DETEK INCORPORATED	ZOLL ELECTRODE	2020-03-24
GUDID 00847946026691 BIO-DETEK INCORPORATED	ZOLL ELECTRODE	2020-03-24
GUDID 00847946018337 BIO-DETEK INCORPORATED	Pro-Padz Radiotransparent	2019-03-25
GUDID 00847946022051 BIO-DETEK INCORPORATED	ECG	2019-01-03
GUDID 00847946022020 BIO-DETEK INCORPORATED	ECG	2019-01-03
GUDID 00847946022013 BIO-DETEK INCORPORATED	ECG	2019-01-03
GUDID 00847946022006 BIO-DETEK INCORPORATED	ECG	2019-01-03
GUDID 00847946024420 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-12-31
GUDID 00847946024413 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-12-31
GUDID 00847946024406 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-12-31
GUDID 00847946024390 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-11-26
GUDID 00847946022037 BIO-DETEK INCORPORATED	ECG	2018-08-13
GUDID 20847946023182 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 20847946023137 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946024178 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023232 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023225 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023218 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023201 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023195 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023188 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023171 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023164 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023157 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023140 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023133 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023126 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023119 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946023102 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946020934 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946020927 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946020903 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946020897 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946020637 BIO-DETEK INCORPORATED	PATIENT CIRCUITS	2018-07-06
GUDID 00847946021016 BIO-DETEK INCORPORATED	ECG	2018-03-29
GUDID 00847946021009 BIO-DETEK INCORPORATED	ECG	2018-03-29
GUDID 00847946020996 BIO-DETEK INCORPORATED	ECG	2018-03-29
GUDID 00847946020989 BIO-DETEK INCORPORATED	ECG	2018-03-29
GUDID 00847946020972 BIO-DETEK INCORPORATED	ECG	2018-03-29
GUDID 00847946020965 BIO-DETEK INCORPORATED	ECG	2018-03-29
GUDID 00847946018443 BIO-DETEK INCORPORATED	MOORE MEDICAL ADULT MFE	2018-03-29
GUDID 00847946018429 BIO-DETEK INCORPORATED	BIO-DETEK MFE	2018-03-29
GUDID 00847946018412 BIO-DETEK INCORPORATED	BIO-DETEK MFE	2018-03-29
GUDID 00847946018405 BIO-DETEK INCORPORATED	BIO-DETEK MFE	2018-03-29
GUDID 00847946018399 BIO-DETEK INCORPORATED	DEP-PACK	2018-03-29
GUDID 00847946018382 BIO-DETEK INCORPORATED	DEP-PACK	2018-03-29
GUDID 00847946018375 BIO-DETEK INCORPORATED	DEP-PACK	2018-03-29
GUDID 00847946016661 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946016494 BIO-DETEK INCORPORATED	STAT-PADZ	2018-03-29
GUDID 00847946016487 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946016470 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946016463 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946016456 BIO-DETEK INCORPORATED	STAT-PADZ	2018-03-29
GUDID 00847946016449 BIO-DETEK INCORPORATED	PEDI-PADZ	2018-03-29
GUDID 00847946016432 BIO-DETEK INCORPORATED	ADULT MFE	2018-03-29
GUDID 00847946016425 BIO-DETEK INCORPORATED	PEDI-PADZ	2018-03-29
GUDID 00847946016418 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946016401 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946016395 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946016388 BIO-DETEK INCORPORATED	ADULT MFE	2018-03-29
GUDID 00847946016371 BIO-DETEK INCORPORATED	POCKETCPR	2018-03-29
GUDID 00847946016364 BIO-DETEK INCORPORATED	PEDI-PADZ	2018-03-29
GUDID 00847946016357 BIO-DETEK INCORPORATED	PEDI-PADZ	2018-03-29
GUDID 00847946016340 BIO-DETEK INCORPORATED	STAT-PADZ	2018-03-29
GUDID 00847946016333 BIO-DETEK INCORPORATED	CPR-D PADZ	2018-03-29
GUDID 00847946016326 BIO-DETEK INCORPORATED	STAT-PADZ II	2018-03-29
GUDID 00847946016319 BIO-DETEK INCORPORATED	CPR STAT-PADZ	2018-03-29
GUDID 00847946016302 BIO-DETEK INCORPORATED	PEDI-PADZ	2018-03-29
GUDID 00847946016296 BIO-DETEK INCORPORATED	DURA-PADZ	2018-03-29
GUDID 00847946016289 BIO-DETEK INCORPORATED	ONESTEP CPR AA	2018-03-29
GUDID 00847946016272 BIO-DETEK INCORPORATED	ONESTEP	2018-03-29
GUDID 00847946016265 BIO-DETEK INCORPORATED	ONESTEP	2018-03-29
GUDID 00847946016258 BIO-DETEK INCORPORATED	ONESTEP	2018-03-29
GUDID 00847946016241 BIO-DETEK INCORPORATED	ONESTEP	2018-03-29
GUDID 00847946016234 BIO-DETEK INCORPORATED	ONESTEP PEDIATRIC	2018-03-29
GUDID 00847946016227 BIO-DETEK INCORPORATED	POCKETCPR	2018-03-29
GUDID 00847946016210 BIO-DETEK INCORPORATED	POCKETCPR	2018-03-29
GUDID 00847946016203 BIO-DETEK INCORPORATED	PEDI-PADZ II	2018-03-29
GUDID 00847946016197 BIO-DETEK INCORPORATED	ONESTEP PEDIATRIC	2018-03-29
GUDID 00847946016180 BIO-DETEK INCORPORATED	ADAPTOR	2018-03-29
GUDID 00847946001469 BIO-DETEK INCORPORATED	PEDI-PADZ	2018-03-29
GUDID 00847946001445 BIO-DETEK INCORPORATED	PRO PADZ	2018-03-29
GUDID 00847946001438 BIO-DETEK INCORPORATED	PEDI PADZ II	2018-03-29
GUDID 00847946000189 BIO-DETEK INCORPORATED	CPR-D PADZ	2018-03-29
PMN K111473 | CBK BIO-DETEK, INC. [ZOLL Medical Corporation]	Pediatric/Adult, Single-Limb, Wye Ventilator Circuit 6 ft.	2017-10-16
PMN K111473 | CBK BIO-DETEK, INC. [ZOLL Medical Corporation]	Pediatric/Adult, Single-Limb, Wye Ventilator Circuit 12 ft.	2017-10-16
PMN K111473 | CBK BIO-DETEK, INC. [ZOLL Medical Corporation]	Infant/Pediatric, Single-Limb, Wye Ventilator Circuit 6 ft.	2017-10-16
PMN K111473 | CBK BIO-DETEK, INC. [ZOLL Medical Corporation]	Infant/Pediatric, Single-Limb, Wye Ventilator Circuit 12 ft.	2017-10-16
PMN K150198 Bio-Detek, Inc.	CPR Dura-Padz Reusable Defibrillation Electrode With Dura-padz Gel	2015-05-02
PMN K150055 BIO-DETEK, INC.	OneStep Pediatric CPR Multi-Function Electrode	2015-05-02
PMN K133441 BIO-DETEK, INC.	ONESTEP CPR II MULTI-FUNCTION ELECTRODE	2014-10-10
PMN K100565 BIO-DETEK, INC.	DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325	2010-11-16
PMN K071321 BIO-DETEK, INC.	POCKETCPR	2007-09-12
PMN K040256 BIO-DETEK, INC.	PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005	2004-04-09
PMN K033771 BIO-DETEK, INC.	BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR	2004-02-27
PMN K984582 BIO-DETEK, INC.	ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX	1999-03-16
PMN K990106 BIO-DETEK, INC.	ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES	1999-02-26
PMN K981802 BIO-DETEK, INC.	ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003	1998-11-25
PMN K964213 BIO-DETEK, INC.	TRACE RITE SOLID GEL ECG ELECTRODES	1996-11-25
PMN K920352 BIO-DETEK, INC.	BIO-DETEK EEG ELECTRODE	1992-08-14
PMN K920264 BIO-DETEK, INC.	BIO-DETEK TRACERITE EEG ELECTRODE	1992-06-02
PMN K912714 BIO-DETEK, INC.	RT40 RADIO TRANSLUCENT	1991-07-25
PMN K853038 BIO-DETEK, INC.	DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES	1986-01-07
PMN K853291 BIO-DETEK, INC.	GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300	1985-10-10

Related Finance Registrations

NCAGE Code	50U13	BIO-DETEK INCORPORATED
CAGE Code	50U13	BIO-DETEK INCORPORATED

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092612638	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	250 CTN
202008113857	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	250 CTN
2020080114796	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	167 CTN
2020073119476	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	167 CTN
202007296955	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	250 CTN
202007284885	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	250 CTN
202007275177	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	250 CTN
2020062011068	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	MEDICAL CABLE	250 CTN