Medical Device Manufacturer · US , Mchenry , IL

Carl Zeiss, Inc.

44 submissions · 44 cleared · Since 1980
44
Total
44
Cleared
0
Denied

Carl Zeiss, Inc. — FDA 510(k) Submissions

Carl Zeiss, Inc. has submitted 44 FDA 510(k) premarket notifications since 1980, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Biomicroscope, Slit-lamp, Ac-powered, Microscope, Surgical, Laser, Ophthalmic, Tray, Surgical, Needle . Use the specialty filter in the sidebar to narrow results.

44 devices
1–25 of 44
VISULAS 532S
K013402 · GEX Powered Laser Surgical... · General & Plastic Surgery
Nov 2001 30d
VISULAS YAG II
K003885 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2001 69d
IOLMASTER
K993357 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Mar 2000 166d
OPMI TWINER SURGICAL MICROSCOPE
K983868 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 1999 88d
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K965139 · HAW Neurological Stereotaxic... · Neurology
Apr 1997 121d
CPC PROBE
K961380 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 1997 341d
HUMPHREY OCT SCANNER
K961171 · HLI Ophthalmoscope, Ac-powered · Radiology
Jun 1996 88d
HUMPHREY FIELD ANALYZER (HFA II)
K954167 · HPT Perimeter, Automatic,... · Ophthalmic
Nov 1995 80d
VISULINK 900 ARGON
K952894 · HQF Laser, Ophthalmic · Ophthalmic
Aug 1995 52d
ZEISS ENDOLIVE STERO ENDOSCOPE
K950985 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 1995 26d
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Sep 1994 553d
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
K942233 · EPT Microscope, Surgical · General & Plastic Surgery
Jul 1994 53d
ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
K936198 · GCT Light Source, Endoscope,... · Gastroenterology & Urology
Apr 1994 98d
ZEISS OPMILAS 144 SURGICAL LASERS
K932376 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 1993 211d
ZEISS VISULAS YAG II LASER
K926452 · GEX Powered Laser Surgical... · General & Plastic Surgery
Nov 1993 333d
ZEISS OPMILAS 144 SURGICAL LASERS
K933322 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 1993 100d
ZEISS DIODE-PUMPED SOLID STATE LASER
K925642 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 1993 308d
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Sep 1993 304d
ZEISS LASER INDIRECT OPHTHALMOSCOPE
K924588 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 1993 302d
ZEISS VISULAS DIODE LASER
K923274 · GEX Powered Laser Surgical... · General & Plastic Surgery
Apr 1993 273d
ZEISS VISULAS ARGON LASER
K923341 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 1992 145d
ZIESS ENDOPROBE
K922735 · HQB Photocoagulator And... · Ophthalmic
Jul 1992 31d
ZEISS MULTI YAG LASER
K920967 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 1992 128d
ND:YAG SURGICAL LASER
K920120 · GEX Powered Laser Surgical... · General & Plastic Surgery
Apr 1992 88d
ZEISS MULTIYAG LASER
K920529 · GEX Powered Laser Surgical... · General & Plastic Surgery
Apr 1992 57d
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