Company ยท US
Carl Zeiss, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2001. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 17 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 4 |
| EPT | Microscope, Surgical | 3 |
| FSH | Tray, Surgical, Needle | 2 |
| HLI | Ophthalmoscope, Ac-Powered | 2 |
| HQF | Laser, Ophthalmic | 2 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 |
| GDC | Table, Operating-Room, Electrical | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 |
| HIT | Tester, Color Vision | 1 |
| HLJ | Ophthalmoscope, Battery-Powered | 1 |
| HLQ | Keratoscope, Ac-Powered | 1 |
| HPL | Device, Fixation, Ac-Powered, Ophthalmic | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 |
| HQB | Photocoagulator And Accessories | 1 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 2001 | K013402 | VISULAS 532S Carl Zeiss, Inc. | GEX |
| Feb 22, 2001 | K003885 | VISULAS YAG II Carl Zeiss, Inc. | GEX |
| Mar 20, 2000 | K993357 | IOLMASTER Carl Zeiss, Inc. | HJO |
| Jan 29, 1999 | K983868 | OPMI TWINER SURGICAL MICROSCOPE Carl Zeiss, Inc. | GEX |
| Apr 23, 1997 | K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM Carl Zeiss, Inc. | HAW |
| Mar 17, 1997 | K961380 | CPC PROBE Carl Zeiss, Inc. | GEX |
| Jun 21, 1996 | K961171 | HUMPHREY OCT SCANNER Carl Zeiss, Inc. | HLI |
| Nov 24, 1995 | K954167 | HUMPHREY FIELD ANALYZER (HFA II) Carl Zeiss, Inc. | HPT |
| Aug 14, 1995 | K952894 | VISULINK 900 ARGON Carl Zeiss, Inc. | HQF |
| Mar 29, 1995 | K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE Carl Zeiss, Inc. | GCJ |
| Sep 28, 1994 | K931478 | ZEISS OPMI L STEREO-LAPAROSCOPE Carl Zeiss, Inc. | HET |
| Jul 1, 1994 | K942233 | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM Carl Zeiss, Inc. | EPT |
| Apr 6, 1994 | K936198 | ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES Carl Zeiss, Inc. | GCT |
| Dec 14, 1993 | K932376 | ZEISS OPMILAS 144 SURGICAL LASERS Carl Zeiss, Inc. | GEX |
| Nov 22, 1993 | K926452 | ZEISS VISULAS YAG II LASER Carl Zeiss, Inc. | GEX |
| Oct 15, 1993 | K933322 | ZEISS OPMILAS 144 SURGICAL LASERS Carl Zeiss, Inc. | GEX |
| Sep 13, 1993 | K925642 | ZEISS DIODE-PUMPED SOLID STATE LASER Carl Zeiss, Inc. | GEX |
| Sep 9, 1993 | K925641 | ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR Carl Zeiss, Inc. | HJO |
| Jul 9, 1993 | K924588 | ZEISS LASER INDIRECT OPHTHALMOSCOPE Carl Zeiss, Inc. | GEX |
| Apr 5, 1993 | K923274 | ZEISS VISULAS DIODE LASER Carl Zeiss, Inc. | GEX |
| Oct 28, 1992 | K923341 | ZEISS VISULAS ARGON LASER Carl Zeiss, Inc. | GEX |
| Jul 9, 1992 | K922735 | ZIESS ENDOPROBE Carl Zeiss, Inc. | HQB |
| Jul 8, 1992 | K920967 | ZEISS MULTI YAG LASER Carl Zeiss, Inc. | GEX |
| Apr 10, 1992 | K920120 | ND:YAG SURGICAL LASER Carl Zeiss, Inc. | GEX |
| Apr 2, 1992 | K920529 | ZEISS MULTIYAG LASER Carl Zeiss, Inc. | GEX |
| Mar 23, 1992 | K915840 | ZEISS MULTIYAG LASER Carl Zeiss, Inc. | GEX |
| Mar 11, 1992 | K915561 | ZEISS MULTIYAG LASER Carl Zeiss, Inc. | GEX |
| Dec 23, 1991 | K912581 | ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) Carl Zeiss, Inc. | HLI |
| Jul 27, 1989 | K894393 | OPMILAS CO2-L Carl Zeiss, Inc. | GEX |
| Jun 8, 1989 | K891584 | S 22 INSTRUMENT STAND Carl Zeiss, Inc. | HRM |
| Dec 15, 1988 | K884876 | S 4 INSTRUMENT STAND Carl Zeiss, Inc. | FSH |
| Sep 13, 1988 | K883581 | OPMI CS Carl Zeiss, Inc. | EPT |
| Sep 13, 1988 | K883578 | S 21 INSTRUMENT STAND Carl Zeiss, Inc. | FSH |
| Jan 27, 1988 | K874160 | ZEISS 40 SL/P PHOTO SLIT LAMP Carl Zeiss, Inc. | HJO |
| Jan 6, 1988 | K874609 | ZEISS VISULAS ARGON LASER Carl Zeiss, Inc. | HQF |
| Dec 23, 1987 | K874241 | OPMI MD SURGICAL MICROSCOPE Carl Zeiss, Inc. | FSO |
| Jun 17, 1986 | K862004 | ZEISS 30 SL-L Carl Zeiss, Inc. | HJO |
| Apr 30, 1986 | K860811 | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S Carl Zeiss, Inc. | EPT |
| Nov 12, 1985 | K854383 | KERATOLUX Carl Zeiss, Inc. | HPL |
| Oct 18, 1985 | K853720 | MOBILE OPERATING TABLE FOR ORL MICROSURGERY Carl Zeiss, Inc. | GDC |
| Oct 15, 1985 | K853723 | ZEISS OPERATING KERATOMETER Carl Zeiss, Inc. | HLQ |
| Oct 4, 1985 | K853891 | INDIRECT OPHTHALMOSCOPE Carl Zeiss, Inc. | HLJ |
| Apr 28, 1983 | K831074 | OSCAR COLOR VISION TESTER Carl Zeiss, Inc. | HIT |
| Mar 20, 1980 | K800552 | ZEISS DISPOSABLE, STERILE SURGICAL DRAPE Carl Zeiss, Inc. | KKX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||