Panels › General, Plastic Surgery › Product code FTD · Class 2
Lamp, Surgical
Regulation 878.4580
0510(k)s in 12 months (29 all time)
0recalls in 12 months (49 all time)
42recalls that name a 510(k)
Top companies in FTD
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular Us Sales, Llc | 0 | 13 |
| Skytron, Div. The KMW Group, Inc | 0 | 11 |
| MAQUET Inc. | 0 | 8 |
| Getinge Usa Sales Inc | 0 | 6 |
| STERIS Corporation | 1 | 5 |
| Draeger Medical, Inc. | 0 | 3 |
| AtriCure, Inc. | 2 | 0 |
| Baxter Healthcare Corporation | 0 | 2 |
| Burton Medical Products Corp. | 2 | 0 |
| Engineered Medical Solutions Co., LLC | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2013 | K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT Engineered Medical Solutions Co., LLC | FTD |
| May 8, 2013 | K130513 | VOLISTA 400; VOLISTA 600 Maquet S.A.S. | FTD |
| Mar 8, 2013 | K123776 | POLARIS 100/200 Drager Medical GmbH | FTD |
| Jun 9, 2011 | K111020 | ATRICURE DISSECTOR AtriCure, Inc. | FTD |
| Jul 8, 2010 | K100234 | HM-LAMP II Hillusa, Inc. | FTD |
| Jun 25, 2010 | K100884 | STRYKER KNIFELIGHT Howmedica Osteonics Corp. | FTD |
| Jun 20, 2007 | K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 Engineered Medical Solutions Co., LLC | FTD |
| Feb 23, 2006 | K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP Waldmann Lighting | FTD |
| Jul 1, 2004 | K041681 | ATRICURE DISSECTOR AtriCure, Inc. | FTD |
| Dec 13, 2001 | K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS Corporation | FTD |
| Jun 7, 2001 | K010724 | SOLA 700,SOLA 500, SOLA 300 Drager Medizintechnik GmbH | FTD |
| Feb 22, 2001 | K003423 | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 St. Francis Medical Equipment Co., Ltd., TW | FTD |
| Jun 30, 1998 | K981717 | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR Stryker Instruments | FTD |
| Aug 22, 1996 | K961122 | STRYKER KNIFELIGHT Stryker Instruments | FTD |
| Oct 18, 1995 | K954263 | XE-LITE Ophthalmic Technologies, Inc., CA | FTD |
| Jun 23, 1994 | K942553 | GENESIS Burton Medical Products Corp. | FTD |
| Feb 22, 1994 | K931675 | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS Medline Industries, Inc. | FTD |
| Nov 12, 1993 | K932451 | HANAULUX 2005 SURGICAL LIGHT Heraeus Instruments GmbH, DE | FTD |
| Jun 25, 1993 | K930897 | MI-15 EXAM SURGICAL LIGHT Medical Illumination, Inc. | FTD |
| Oct 13, 1989 | K895715 | HANAULUX(R) 2000 W.C. Heraeus GmbH, DE | FTD |
| Jul 18, 1988 | K882613 | ALM SURGICAL LAMPS Alm Surgical Equipment, Inc. | FTD |
| Jan 24, 1986 | K860088 | PL EXAM LIGHT Burton Medical Products Corp. | FTD |
| Apr 24, 1984 | K841360 | MINOR SURGICAL LIGHT MODEL 180 American Sterilizer Co. | FTD |
| Dec 3, 1982 | K823360 | SURGICAL LIGHT Amsco Co. | FTD |
| Jul 20, 1981 | K811728 | CASTLE & RITTER MINOR SURG. & EXAM LT Sybron Corp. | FTD |
| Jun 30, 1980 | K801353 | PARKE-DAVIS SURGICAL LIGHT Warner-Lambert Co. | FTD |
| Jun 17, 1977 | K770861 | SURGICAL COLDLIGHT, AX8 Affiliated Hospital Products, Inc. | FTD |
| Apr 14, 1977 | K770568 | SURGICAL ILLUMINATOR (SIL) Fiber Optics Engineering, Inc. | FTD |
| Apr 14, 1977 | K770567 | LIGHT, EXAMINATION, MEDICAL (MEL) Fiber Optics Engineering, Inc. | FTD |
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