Atlas FDA

FTD

29 FDA 510(k) clearances · Product code

46 daysmedian time to decision
163 days90th percentile
29clearances measured

FDA profile

Official device name
Lamp, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 65 · 2022: 136 · 2023: 251 · 2024: 144 · 2025: 85 · 2026: 40
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT (K133425)Engineered Medical Solutions Co., LLC2013-12-05
VOLISTA 400; VOLISTA 600 (K130513)Maquet S.A.S.2013-05-08
POLARIS 100/200 (K123776)Drager Medical GmbH2013-03-08
ATRICURE DISSECTOR (K111020)AtriCure, Inc.2011-06-09
HM-LAMP II (K100234)Hillusa, Inc.2010-07-08
STRYKER KNIFELIGHT (K100884)Howmedica Osteonics Corp.2010-06-25
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (K071180)Engineered Medical Solutions Co., LLC2007-06-20
HALUX IRIS EXAMINATION AND SURGICAL LAMP (K053364)Waldmann Lighting2006-02-23
ATRICURE DISSECTOR (K041681)AtriCure, Inc.2004-07-01
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (K013242)STERIS Corporation2001-12-13
SOLA 700,SOLA 500, SOLA 300 (K010724)Drager Medizintechnik GmbH2001-06-07
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 (K003423)St. Francis Medical Equipment Co., Ltd.2001-02-22
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR (K981717)Stryker Instruments1998-06-30
STRYKER KNIFELIGHT (K961122)Stryker Instruments1996-08-22
XE-LITE (K954263)Ophthalmic Technologies, Inc.1995-10-18
GENESIS (K942553)Burton Medical Products Corp.1994-06-23
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS (K931675)Medline Industries, Inc.1994-02-22
HANAULUX 2005 SURGICAL LIGHT (K932451)Heraeus Instruments GmbH1993-11-12
MI-15 EXAM SURGICAL LIGHT (K930897)Medical Illumination, Inc.1993-06-25
HANAULUX(R) 2000 (K895715)W.C. Heraeus GmbH1989-10-13
ALM SURGICAL LAMPS (K882613)Alm Surgical Equipment, Inc.1988-07-18
PL EXAM LIGHT (K860088)Burton Medical Products Corp.1986-01-24
MINOR SURGICAL LIGHT MODEL 180 (K841360)American Sterilizer Co.1984-04-24
SURGICAL LIGHT (K823360)Amsco Co.1982-12-03
CASTLE & RITTER MINOR SURG. & EXAM LT (K811728)Sybron Corp.1981-07-20
PARKE-DAVIS SURGICAL LIGHT (K801353)Warner-Lambert Co.1980-06-30
SURGICAL COLDLIGHT, AX8 (K770861)Affiliated Hospital Products, Inc.1977-06-17
SURGICAL ILLUMINATOR (SIL) (K770568)Fiber Optics Engineering, Inc.1977-04-14
LIGHT, EXAMINATION, MEDICAL (MEL) (K770567)Fiber Optics Engineering, Inc.1977-04-14

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Every clearance here is in the API, with alerts when new ones post.