Device, Medical Examination, Ac Powered
FDA product code KZF · Class I (low risk) · 21 CFR 880.6320 · General Hospital
37510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Medical Illumination, Inc. 8
- Burton Medical Products Corp. 7
- Welch Allyn, Inc. 6
- Meddev International Corp. 2
- Nizar A. Mullani 1
- Rudolf Riester GmbH & Co. KG 1
- Lighthouse For The Blind 1
- Skytron, Div. The KMW Group, Inc 1
- Berchtold Holding GmbH 1
- Midmark Corp. 1
- Vitajet Corp. 1
- Air-Shields, Inc. 1
- Olympic Medical Corp. 1
- Jedmed Instrument Co. 1
- Good-Lite Co. 1
- Lada Intl., Inc. 1
- Tensor Industries, Inc. 1
- Abco Dealers, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954943 | NevoscopeKZF · Traditional | Nizar A. Mullani | 03/27/1996SE |
| K952835 | Welch Allyn Video EpiscopeKZF · Traditional | Welch Allyn, Inc. | 09/22/1995SE |
| K945507 | H 5100, H 5200, H 5300KZF · Traditional | Rudolf Riester GmbH & Co. KG | 12/09/1994SE |
| K941869 | Splint, Pneumatic, Arm & Splint, Pneumatic, LegKZF · Traditional | The Lighthouse For the Blind, Inc. | 08/03/1994SE |
| K936088 | Wave Fluorescent MagnifierKZF · Traditional | Burton Medical Products Corp. | 04/26/1994SE |
| K940284 | Meddev Multarray Medical Examining Light ModificationKZF · Traditional | Meddev International Corp. | 02/28/1994SE |
| K933564 | Skytron Exam LightKZF · Traditional | Skytron, Div. the Kmw Group, Inc. | 02/10/1994SE |
| K935832 | ChromophareKZF · Traditional | Berchtold Holding GmbH | 02/03/1994SE |
| K934259 | Ac-Powered Medical Examination LightKZF · Traditional | Welch Allyn, Inc. | 01/28/1994SE |
| K932719 | Ritter Model 158 and 159 Exam LightsKZF · Traditional | Midmark Corp. | 12/02/1993SE |
| K924447 | VitapenKZF · Traditional | Vitajet Corp. | 09/27/1993SE |
| K931197 | Meddev Multarray (TM) Medical Examination LightKZF · Traditional | Meddev International Corp. | 09/23/1993SE |
| K931645 | Halux TasklightKZF · Traditional | Burton Medical Products Corp. | 08/20/1993SE |
| K931646 | MI-4 Variable Spot LightKZF · Traditional | Medical Illumination, Inc. | 08/19/1993SE |
| K931026 | MI-5 Diagnostic LightKZF · Traditional | Medical Illumination, Inc. | 08/19/1993SE |
| K925710 | M.E.D. LightKZF · Traditional | Medical Illumination, Inc. | 06/04/1993SE |
| K922282 | Illuminator Viii Ultra/SpotKZF · Traditional | Medical Illumination, Inc. | 03/04/1993SE |
| K922278 | Illuminator IIIKZF · Traditional | Medical Illumination, Inc. | 03/04/1993SE |
| K922281 | Illuminator Vii Mini/Spot LightKZF · Traditional | Medical Illumination, Inc. | 02/05/1993SE |
| K922280 | Illuminator Vii Mini/Lum LightKZF · Traditional | Medical Illumination, Inc. | 02/05/1993SE |
| K922277 | Illuminator IIKZF · Traditional | Medical Illumination, Inc. | 02/05/1993SE |
| K921493 | LS100 Halogen Examination Light, Model No: 44100KZF · Traditional | Welch Allyn, Inc. | 11/03/1992SE |
| K922150 | Examination LampKZF · Traditional | Air-Shields, Inc. | 07/21/1992SE |
| K920103 | Episcope, Model 47300KZF · Traditional | Welch Allyn, Inc. | 04/28/1992SE |
| K901706 | Light, Head, ExaminationKZF · Traditional | Burton Medical Products Corp. | 07/19/1990SE |
| K896611 | Olympic Light-WarmKZF · Traditional | Olympic Medical Corp. | 02/06/1990SE |
| K896962 | Tiny Halogen Exam LightKZF · Traditional | Jedmed Instrument Co. | 12/29/1989SE |
| K893808 | Model 0450000, Opal Medical Exam LightKZF · Traditional | Burton Medical Products Corp. | 08/15/1989SE |
| K893807 | Model 0183010, Pearl Medical Exam LightKZF · Traditional | Burton Medical Products Corp. | 08/15/1989SE |
| K861289 | Basic LightKZF · Traditional | Burton Medical Products Corp. | 04/18/1986SE |
| K852949 | Welch Allyn #48100 Task Lite W/Accessories AS ListKZF · Traditional | Welch Allyn, Inc. | 09/04/1985SE |
| K851742 | Medical Examination LightsKZF · Traditional | Burton Medical Products Corp. | 05/13/1985SE |
| K842135 | Hi-Lo Floor Standing Exam. LightKZF · Traditional | Good-Lite Co. | 07/06/1984SE |
| K812142 | Lic 180 Medical LampsKZF · Traditional | Lada Intl., Inc. | 08/13/1981SE |
| K800067 | Vita Lamp, Model 0350KZF · Traditional | Tensor Industries, Inc. | 05/08/1980SE |
| K800230 | Abco Examination Lamp (Gooseneck Type)KZF · Traditional | Abco Dealers, Inc. | 02/26/1980SE |
| K780628 | Halogen Exam. Lite #48400KZF · Traditional | Welch Allyn, Inc. | 06/06/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1436-2026 Class II | MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved…Due to battery component overheating while charging resulting in melting of internal components and causing… | MRIMed Inc. | 10/13/2025Open, Classified |
| Z-2248-2017 Class II | Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights…The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the… | Stryker Communications | 04/21/2017Terminated |
| Z-1501-2017 Class II | Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1992-2013 Class II | Stryker Visum 300 Ceiling-mounted Exam Light.Potential incomplete final weld on the drop tube flange. | Stryker Communications | 07/25/2013Terminated |