Battery, Replacement, Rechargeable
FDA product code MOQ · Class I (low risk) · 21 CFR 878.4820 · General, Plastic Surgery
3510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081713 | Vertebral Access System by VidacareMOQ · Traditional | Vidacare Corporation | 11/21/2008SE |
| K013133 | Nordix Inc Rechargeable Battery Part Number 2116MOQ · Traditional | Nordix, Inc. | 11/13/2001SE |
| K980224 | Alexander Manufacturing Co. Rechargeable Battery Part Number MS822MOQ · Traditional | Alexander Mfg. Co. | 04/02/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0280-2025 Class II | KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in…The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings… | Pro-Dex Inc | 09/23/2024Open, Classified |
| Z-1994-2016 Class II | Universal Battery Charger II (UBC II)The device is reported to enter safe mode and is no longer able to charge batteries. | The Anspach Effort, Inc. | 01/15/2016Terminated |
| Z-1095-2016 Class II | Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max…The sterile battery may contain particulates within the sterile package. | Pro-Dex Inc | 12/23/2015Terminated |
| Z-1094-2016 Class II | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin…The sterile battery may contain particulates within the sterile package. | Pro-Dex Inc | 12/23/2015Terminated |
| Z-2126-2016 Class II | Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort…Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead… | The Anspach Effort, Inc. | 11/25/2015Terminated |
| Z-0156-2007 | DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin…Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger… | Lumiport, LLC | 09/28/2006Terminated |