Carl Zeiss Inc

FDA Filings

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

Carl Zeiss Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Scott A. Margolin
• Carl Zeiss Suzhou Co., Ltd.

FDA Registration(s)

• Registration Number: 2431026
• FEI Number: 2431026
• Name: CARL ZEISS MICROSCOPY, LLC
• Owner & Operator: Carl Zeiss Inc.
• Contact Address: 1 North Broadway ; White Plains NY 10601 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: One North Broadway ; White Plains, NY 10601 US

• Registration Number: 3005060446
• FEI Number: 3005060446
• Name: Scott A. Margolin
• Owner & Operator: Carl Zeiss Inc.
• Contact Address: 1 North Broadway ; White Plains NY 10601 US
• US Agent:
  • Scott A. Margolin
  • CARL ZEISS INC.
  • 914 6817880
  • 914 6817485
  • scott.margolin@zeiss.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: One North Broadway ; White Plains, NY 10601 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3008564898
• FEI Number: 3008564898
• Name: Carl Zeiss Suzhou Co., Ltd.
• Owner & Operator: Carl Zeiss Inc.
• Contact Address: 1 North Broadway ; White Plains NY 10601 US
• US Agent:
  • Scott Margolin
  • Carl Zeiss, Inc.
  • 914 6817880
  • scott.margolin@zeiss.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Modern Industrial Square 3B No. 333 Xing Pu Road; SIP, Suzhou Jiangsu, 215126 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K171007 | NBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Fluorescence	2018-06-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	Stemi 508	2016-08-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	SteREO Discovery.V8	2016-08-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	Axiovert .A1	2016-08-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 7	2016-08-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 5	2016-08-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	Axiolab 5	2016-08-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	Axio Observer	2016-08-11
MTX Scott A. Margolin [Carl Zeiss Inc.]	Axio Lab.A1	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 508	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery.V8	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiovert .A1	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Observer	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Lab.A1	2016-08-11
HOO Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Humphrey FDT Model 710	2012-04-25
IBM Scott A. Margolin [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axio Lab A1	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBM Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Lab A1	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
IBL Scott A. Margolin [Carl Zeiss Inc.]	Primovert	2005-03-15
IBL Scott A. Margolin [Carl Zeiss Inc.]	Primovert iLED	2005-03-15
IBL Scott A. Margolin [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBL Scott A. Margolin [Carl Zeiss Inc.]	Axio Observer	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primovert	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primovert iLED	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Observer	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	SteREO LUMAR	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	SteREO Discovery V8	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	SteREO Discovery V20	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	SteREO Discovery V12	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axio Lab A1	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBK Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO LUMAR	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V8	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V20	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V12	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Lab A1	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	SterREO Discovery V12	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Stemi DV4	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Stemi 508	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Stemi 2000	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Stemi 2000 CS	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Stemi 2000 C	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	SteREO Lumar V12	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	SteREO Discovery V20	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	SteREO Discovery V.8	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	PRIMO STAR	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBJ Scott A. Margolin [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SterREO Discovery V12	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi DV4	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 508	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 2000	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 2000 CS	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 2000 C	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Lumar V12	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V20	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V.8	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	PRIMO STAR	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
PMN K013402 CARL ZEISS, INC.	VISULAS 532S	2001-11-14
PMN K003885 CARL ZEISS, INC.	VISULAS YAG II	2001-02-22
PMN K993357 CARL ZEISS, INC.	IOLMASTER	2000-03-20
PMN K983868 CARL ZEISS, INC.	OPMI TWINER SURGICAL MICROSCOPE	1999-01-29
PMN K965139 CARL ZEISS, INC.	SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM	1997-04-23
PMN K961380 CARL ZEISS, INC.	CPC PROBE	1997-03-17
PMN K961171 CARL ZEISS, INC.	HUMPHREY OCT SCANNER	1996-06-21
PMN K954167 CARL ZEISS, INC.	HUMPHREY FIELD ANALYZER (HFA II)	1995-11-24
PMN K952894 CARL ZEISS, INC.	VISULINK 900 ARGON	1995-08-14
PMN K950985 CARL ZEISS, INC.	ZEISS ENDOLIVE STERO ENDOSCOPE	1995-03-29
PMN K931478 CARL ZEISS, INC.	ZEISS OPMI L STEREO-LAPAROSCOPE	1994-09-28
PMN K942233 CARL ZEISS, INC.	MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM	1994-07-01
PMN K936198 CARL ZEISS, INC.	ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES	1994-04-06
PMN K932376 CARL ZEISS, INC.	ZEISS OPMILAS 144 SURGICAL LASERS	1993-12-14
PMN K926452 CARL ZEISS, INC.	ZEISS VISULAS YAG II LASER	1993-11-22
PMN K933322 CARL ZEISS, INC.	ZEISS OPMILAS 144 SURGICAL LASERS	1993-10-15
PMN K925642 CARL ZEISS, INC.	ZEISS DIODE-PUMPED SOLID STATE LASER	1993-09-13
PMN K925641 CARL ZEISS, INC.	ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR	1993-09-09
PMN K924588 CARL ZEISS, INC.	ZEISS LASER INDIRECT OPHTHALMOSCOPE	1993-07-09
PMN K923274 CARL ZEISS, INC.	ZEISS VISULAS DIODE LASER	1993-04-05
HRM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	OPMI LUMERA 300	1992-12-18
FSO Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	OPMI LUMERA 300	1992-12-18
EPT Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Reusable Asepsis Caps	1992-12-18
EPT Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	EXTARO 300	1992-12-18
PMN K923341 CARL ZEISS, INC.	ZEISS VISULAS ARGON LASER	1992-10-28
PMN K922735 CARL ZEISS, INC.	ZIESS ENDOPROBE	1992-07-09
PMN K920967 CARL ZEISS, INC.	ZEISS MULTI YAG LASER	1992-07-08
PMN K920120 CARL ZEISS, INC.	ND:YAG SURGICAL LASER	1992-04-10
PMN K920529 CARL ZEISS, INC.	ZEISS MULTIYAG LASER	1992-04-02
PMN K915840 CARL ZEISS, INC.	ZEISS MULTIYAG LASER	1992-03-23
PMN K915561 CARL ZEISS, INC.	ZEISS MULTIYAG LASER	1992-03-11
PMN K912581 CARL ZEISS, INC.	ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)	1991-12-23
PMA P850083S008 CARL ZEISS, INC.	VISULAS ND:YAG LASER	1989-08-02
PMN K894393 CARL ZEISS, INC.	OPMILAS CO2-L	1989-07-27
PMN K891584 CARL ZEISS, INC.	S 22 INSTRUMENT STAND	1989-06-08
PMN K884876 CARL ZEISS, INC.	S 4 INSTRUMENT STAND	1988-12-15
PMN K883581 CARL ZEISS, INC.	OPMI CS	1988-09-13
PMN K883578 CARL ZEISS, INC.	S 21 INSTRUMENT STAND	1988-09-13
PMA P850083S007 CARL ZEISS, INC.	VISULAS ND:YAG LASER	1988-07-15
PMN K874160 CARL ZEISS, INC.	ZEISS 40 SL/P PHOTO SLIT LAMP	1988-01-27
PMN K874609 CARL ZEISS, INC.	ZEISS VISULAS ARGON LASER	1988-01-06
PMN K874241 CARL ZEISS, INC.	OPMI MD SURGICAL MICROSCOPE	1987-12-23
PMA P850083S006 CARL ZEISS, INC.	VISULAS ND:YAG LASER	1987-10-05
PMA P850083S005 CARL ZEISS, INC.	VISULAS ND:YAG LASER	1987-09-30
PMA P850083S004 CARL ZEISS, INC.	VISULAS ND:YAG LASER	1987-03-31
PMA P850083S001 CARL ZEISS, INC.	VISULAS ND:YAG LASER	1987-03-10
PMA P850083S003 CARL ZEISS, INC.	VISULAS ND:YAG LASER	1986-12-04
PMN K862004 CARL ZEISS, INC.	ZEISS 30 SL-L	1986-06-17
PMN K860811 CARL ZEISS, INC.	ZEISS VOICE CONTROL SYSTEM FOR OPMI'S	1986-04-30
PMN K854383 CARL ZEISS, INC.	KERATOLUX	1985-11-12
PMN K853720 CARL ZEISS, INC.	MOBILE OPERATING TABLE FOR ORL MICROSURGERY	1985-10-18
PMN K853723 CARL ZEISS, INC.	ZEISS OPERATING KERATOMETER	1985-10-15
PMN K853891 CARL ZEISS, INC.	INDIRECT OPHTHALMOSCOPE	1985-10-04
PMN K831074 CARL ZEISS, INC.	OSCAR COLOR VISION TESTER	1983-04-28
PMN K800552 CARL ZEISS, INC.	ZEISS DISPOSABLE, STERILE SURGICAL DRAPE	1980-03-20

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Related Finance Registrations

NCAGE Code	0VZ56	CARL ZEISS, INC
NCAGE Code	1F7X9	CARL ZEISS INC.!DBA HUMPHREY SYSTEMS
CAGE Code	0VZ56	CARL ZEISS, INC
CAGE Code	1F7X9	CARL ZEISS, INC. HUMPHREY SYSTEMS
SEC	0001618019	Carl Zeiss Inc.