Carl Zeiss, Inc.

Thornwood, NY, US

Carl Zeiss, Inc. appears in FDA device records in Thornwood, NY. FDA records list 44 510(k) clearances between 1980-03-20 and 2001-11-14, 7 PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 44
PMA records: 7
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 44 510(k) clearances for Carl Zeiss, Inc. between 1980 and 2001. The busiest year on record is 1992, with 7. The most recent is 2001, with 2.

Clearances by year, as a table

510(k) clearance decisions for Carl Zeiss, Inc., by decision year
Year	Clearances
1980	1
1983	1
1985	4
1986	2
1987	1
1988	5
1989	2
1991	1
1992	7
1993	7
1994	3
1995	3
1996	1
1997	2
1999	1
2000	1
2001	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K013402	VISULAS 532S	GEX	Substantially Equivalent	2001-11-14
K003885	VISULAS YAG II	GEX	Substantially Equivalent	2001-02-22
K993357	IOLMASTER	HJO	Substantially Equivalent	2000-03-20
K983868	OPMI TWINER SURGICAL MICROSCOPE	GEX	Substantially Equivalent	1999-01-29
K965139	SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM	HAW	Substantially Equivalent	1997-04-23
K961380	CPC PROBE	GEX	Substantially Equivalent	1997-03-17
K961171	HUMPHREY OCT SCANNER	HLI	Substantially Equivalent	1996-06-21
K954167	HUMPHREY FIELD ANALYZER (HFA II)	HPT	Substantially Equivalent	1995-11-24
K952894	VISULINK 900 ARGON	HQF	Substantially Equivalent	1995-08-14
K950985	ZEISS ENDOLIVE STERO ENDOSCOPE	GCJ	Substantially Equivalent	1995-03-29
K931478	ZEISS OPMI L STEREO-LAPAROSCOPE	HET	Substantially Equivalent	1994-09-28
K942233	MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM	EPT	Substantially Equivalent	1994-07-01
K936198	ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES	GCT	Substantially Equivalent	1994-04-06
K932376	ZEISS OPMILAS 144 SURGICAL LASERS	GEX	Substantially Equivalent	1993-12-14
K926452	ZEISS VISULAS YAG II LASER	GEX	Substantially Equivalent	1993-11-22
K933322	ZEISS OPMILAS 144 SURGICAL LASERS	GEX	Substantially Equivalent	1993-10-15
K925642	ZEISS DIODE-PUMPED SOLID STATE LASER	GEX	Substantially Equivalent	1993-09-13
K925641	ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR	HJO	Substantially Equivalent	1993-09-09
K924588	ZEISS LASER INDIRECT OPHTHALMOSCOPE	GEX	Substantially Equivalent	1993-07-09
K923274	ZEISS VISULAS DIODE LASER	GEX	Substantially Equivalent	1993-04-05
K923341	ZEISS VISULAS ARGON LASER	GEX	Substantially Equivalent	1992-10-28
K922735	ZIESS ENDOPROBE	HQB	Substantially Equivalent	1992-07-09
K920967	ZEISS MULTI YAG LASER	GEX	Substantially Equivalent	1992-07-08
K920120	ND:YAG SURGICAL LASER	GEX	Substantially Equivalent	1992-04-10
K920529	ZEISS MULTIYAG LASER	GEX	Substantially Equivalent	1992-04-02
K915840	ZEISS MULTIYAG LASER	GEX	Substantially Equivalent	1992-03-23
K915561	ZEISS MULTIYAG LASER	GEX	Substantially Equivalent	1992-03-11
K912581	ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)	HLI	Substantially Equivalent	1991-12-23
K894393	OPMILAS CO2-L	GEX	Substantially Equivalent	1989-07-27
K891584	S 22 INSTRUMENT STAND	HRM	Substantially Equivalent	1989-06-08
K884876	S 4 INSTRUMENT STAND	FSH	Substantially Equivalent	1988-12-15
K883581	OPMI CS	EPT	Substantially Equivalent	1988-09-13
K883578	S 21 INSTRUMENT STAND	FSH	Substantially Equivalent	1988-09-13
K874160	ZEISS 40 SL/P PHOTO SLIT LAMP	HJO	Substantially Equivalent	1988-01-27
K874609	ZEISS VISULAS ARGON LASER	HQF	Substantially Equivalent	1988-01-06
K874241	OPMI MD SURGICAL MICROSCOPE	FSO	Substantially Equivalent	1987-12-23
K862004	ZEISS 30 SL-L	HJO	Substantially Equivalent	1986-06-17
K860811	ZEISS VOICE CONTROL SYSTEM FOR OPMI'S	EPT	Substantially Equivalent	1986-04-30
K854383	KERATOLUX	HPL	Substantially Equivalent	1985-11-12
K853720	MOBILE OPERATING TABLE FOR ORL MICROSURGERY	GDC	Substantially Equivalent	1985-10-18
K853723	ZEISS OPERATING KERATOMETER	HLQ	Substantially Equivalent	1985-10-15
K853891	INDIRECT OPHTHALMOSCOPE	HLJ	Substantially Equivalent	1985-10-04
K831074	OSCAR COLOR VISION TESTER	HIT	Substantially Equivalent	1983-04-28
K800552	ZEISS DISPOSABLE, STERILE SURGICAL DRAPE	KKX	Substantially Equivalent	1980-03-20

Registered establishments

No FDA establishment registrations recorded against this company.

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain