FDA Product Code
FDA Product Code FTD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4580
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT | Engineered Medical Solutions Co., LLC | 2013-12-05 | Special | PDF ↗ |
| K130513 | VOLISTA 400; VOLISTA 600 | Maquet S.A.S. | 2013-05-08 | Special | PDF ↗ |
| K123776 | POLARIS 100/200 | Drager Medical GmbH | 2013-03-08 | Abbreviated | PDF ↗ |
| K111020 | ATRICURE DISSECTOR | AtriCure, Inc. | 2011-06-09 | Special | PDF ↗ |
| K100234 | HM-LAMP II | Hillusa, Inc. | 2010-07-08 | Traditional | PDF ↗ |
| K100884 | STRYKER KNIFELIGHT | Howmedica Osteonics Corp. | 2010-06-25 | Traditional | PDF ↗ |
| K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007-06-20 | Traditional | PDF ↗ |
| K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP | Waldmann Lighting | 2006-02-23 | Traditional | PDF ↗ |
| K041681 | ATRICURE DISSECTOR | AtriCure, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | STERIS Corporation | 2001-12-13 | Abbreviated | PDF ↗ |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | Drager Medizintechnik GmbH | 2001-06-07 | Abbreviated | PDF ↗ |
| K003423 | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | St. Francis Medical Equipment Co., Ltd. | 2001-02-22 | Traditional | PDF ↗ |
| K981717 | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | Stryker Instruments | 1998-06-30 | Traditional | PDF ↗ |
| K961122 | STRYKER KNIFELIGHT | Stryker Instruments | 1996-08-22 | Traditional | PDF ↗ |
| K954263 | XE-LITE | Ophthalmic Technologies, Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K942553 | GENESIS | Burton Medical Products Corp. | 1994-06-23 | Traditional | PDF ↗ |
| K931675 | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | Medline Industries, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K932451 | HANAULUX 2005 SURGICAL LIGHT | Heraeus Instruments GmbH | 1993-11-12 | Traditional | PDF ↗ |
| K930897 | MI-15 EXAM SURGICAL LIGHT | Medical Illumination, Inc. | 1993-06-25 | Traditional | PDF ↗ |
| K895715 | HANAULUX(R) 2000 | W.C. Heraeus GmbH | 1989-10-13 | Traditional | PDF ↗ |
| K882613 | ALM SURGICAL LAMPS | Alm Surgical Equipment, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K860088 | PL EXAM LIGHT | Burton Medical Products Corp. | 1986-01-24 | Traditional | PDF ↗ |
| K841360 | MINOR SURGICAL LIGHT MODEL 180 | American Sterilizer Co. | 1984-04-24 | Traditional | PDF ↗ |
| K823360 | SURGICAL LIGHT | Amsco Co. | 1982-12-03 | Traditional | PDF ↗ |
| K811728 | CASTLE & RITTER MINOR SURG. & EXAM LT | Sybron Corp. | 1981-07-20 | Traditional | PDF ↗ |
| K801353 | PARKE-DAVIS SURGICAL LIGHT | Warner-Lambert Co. | 1980-06-30 | Traditional | PDF ↗ |
| K770861 | SURGICAL COLDLIGHT, AX8 | Affiliated Hospital Products, Inc. | 1977-06-17 | Traditional | PDF ↗ |
| K770567 | LIGHT, EXAMINATION, MEDICAL (MEL) | Fiber Optics Engineering, Inc. | 1977-04-14 | Traditional | PDF ↗ |
| K770568 | SURGICAL ILLUMINATOR (SIL) | Fiber Optics Engineering, Inc. | 1977-04-14 | Traditional | PDF ↗ |
Product code FTD · Class II · General, Plastic Surgery. Data: openFDA.