Panels › Ophthalmic › Product code HNO · Class 1
Keratome, Ac-Powered
Regulation 886.4370
0510(k)s in 12 months (83 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in HNO
| Company | 510(k)s | Recalls |
|---|---|---|
| Bausch & Lomb, Inc. | 4 | 4 |
| Med-Logics, Inc. | 7 | 1 |
| Millennium Biomedical, Inc. | 5 | 0 |
| Oasis Medical, Inc. | 5 | 0 |
| Micro Specialties, Inc. | 4 | 0 |
| Moria SA | 4 | 0 |
| Surgin Surgical Instrumentation, Inc. | 4 | 0 |
| AMO Manufacturing USA, LLC | 0 | 3 |
| Howard Instruments, Inc. | 3 | 0 |
| Lasersight Technologies, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 13, 2018 | K173371 | VisuMax Femtosecond Laser Carl Zeiss Meditec, Inc. | HNO |
| Oct 26, 2017 | K172994 | EPI K Console Moria SA, FR | HNO |
| Jan 16, 2009 | K072102 | EPIVISION SL SYSTEM Gebauer Medizintechnik GmbH | HNO |
| Aug 1, 2008 | K082043 | CARRIAZO-PENDULAR MICROKERATOME Schwind Eye-Tech-Solutions GmbH & Co. KG, DE | HNO |
| Sep 6, 2006 | K062465 | ZYOPTIX XP EPI SEPARATOR SYSTEM Bausch & Lomb, Inc. | HNO |
| Mar 23, 2006 | K052891 | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM Hawken Industries | HNO |
| Jul 6, 2005 | K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME Norwood Abbey , Ltd., AU | HNO |
| Mar 25, 2005 | K043183 | EPI-K Moria SA, FR | HNO |
| Jan 31, 2005 | K043150 | AMADEUS II EPIKERATOME Sis Ltd., Surgical Instrument Systems | HNO |
| Nov 16, 2004 | K042083 | MODIFICATION TO VISITOME 20-10 MICROKERATOME Biovision AG | HNO |
| Oct 28, 2004 | K042810 | CENTURION SES EPIKERATOME Norwood Abbey , Ltd., AU | HNO |
| Oct 13, 2004 | K041110 | MB 105 MILLENNIUM BLADES Millennium Biomedical, Inc. | HNO |
| Sep 15, 2004 | K041206 | EPITOME SYSTEM Gebauer Medizintechnik GmbH | HNO |
| Aug 30, 2004 | K032910 | CARRIAZO PENDULAR Schwind Eye-Tech-Solutions GmbH & Co. KG | HNO |
| Jun 18, 2004 | K032836 | M3 MICROKERATOME Moria SA, FR | HNO |
| May 25, 2004 | K033457 | M2 COMPATIBLE MICROKERATOME BLADE Micro Specialties, Inc. | HNO |
| Mar 26, 2004 | K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 Surgin Surgical Instrumentation, Inc. | HNO |
| Mar 22, 2004 | K040204 | ZYOPTIX XP MICROKERATOME Bausch & Lomb, Inc. | HNO |
| Jan 30, 2004 | K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD Surgin Surgical Instrumentation, Inc. | HNO |
| Jan 13, 2004 | K033293 | MED-LOGICS, MODEL ML7090 Med-Logics, Inc. | HNO |
| Oct 20, 2003 | K032978 | MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME Ciba Vision Corporation | HNO |
| Aug 26, 2003 | K032297 | DISPOSABLE N-PE MICKROKERATOME BLADES Oasis Medical, Inc. | HNO |
| Aug 21, 2003 | K031735 | CENTURION SES EPIKERATOME Ciba Vision Corporation | HNO |
| Jun 19, 2003 | K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES Oasis Medical, Inc. | HNO |
| Jun 17, 2003 | K030891 | SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK Surgistar, Inc. | HNO |
| Dec 16, 2002 | K020482 | KERATOME BLADE 200200 & 600600 Micro Specialties, Inc. | HNO |
| Nov 15, 2002 | K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB Med-Logics, Inc. | HNO |
| Oct 11, 2002 | K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB Med-Logics, Inc. | HNO |
| Oct 3, 2002 | K022205 | DISPOSABLE N-PE MICROKERATOME BLADES Oasis Medical, Inc. | HNO |
| Jun 19, 2002 | K021640 | HANSATOME EXCELLUS MICROKERATOME Bausch & Lomb, Inc. | HNO |
| Apr 19, 2002 | K020079 | BLADEWORKS MICROKERATOME BLADE, MODEL 7061 Blade Works, Inc. | HNO |
| Mar 11, 2002 | K014000 | VISTITOME 20-10 MICROKERATOME Biovision AG | HNO |
| Feb 15, 2002 | K020122 | MB 102 MILLENNIUM BLADES Millennium Biomedical, Inc. | HNO |
| Feb 15, 2002 | K011833 | MB 103 MILLENNIUM BLADES Millennium Biomedical, Inc. | HNO |
| Dec 13, 2001 | K013337 | PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI Surgin, Inc. | HNO |
| Nov 6, 2001 | K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB Surgin Surgical Instrumentation, Inc. | HNO |
| Jun 22, 2001 | K010872 | ML BLADE, MODEL ML7030 Med-Logics, Inc. | HNO |
| Apr 27, 2001 | K010260 | HANSATOME MICROKERATOME Bausch & Lomb, Inc. | HNO |
| Mar 8, 2001 | K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES Oasis Medical, Inc. | HNO |
| Feb 22, 2001 | K002515 | MEDLOGICS ML 4000, MODEL 4000 Med-Logics, Inc. | HNO |
| Dec 11, 2000 | K003143 | MILLENNIUM BLADES, MODEL MB101 Millennium Biomedical, Inc. | HNO |
| Oct 18, 2000 | K002849 | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES Surgical Specialties Corp | HNO |
| Oct 2, 2000 | K001464 | DISPOSABLE H-PE MICROKERATOME BLADES Oasis | HNO |
| Sep 21, 2000 | K001176 | DISPOSABLE MICROKERATOME BLADES-PE Oasis Medical, Inc. | HNO |
| Sep 12, 2000 | K001806 | REFRACTIVE SURGERY BLADES Millennium Biomedical, Inc. | HNO |
| May 5, 2000 | K001144 | ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS Lasersight Technologies, Inc. | HNO |
| Mar 20, 2000 | K993225 | BLADEWORKS MICROKERATOME BLADE Blade Works, Inc. | HNO |
| Mar 16, 2000 | K993122 | MSP M/K BLADE Medical Sterile Products, Inc. | HNO |
| Mar 15, 2000 | K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 Surgin Surgical Instrumentation, Inc. | HNO |
| Feb 10, 2000 | K993190 | ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) Surgical Instrument Systems (Sis), Ltd. | HNO |
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