Home › ROCHESTER ELECTRO-MEDICAL, INC. › UltraPoint™
UltraPoint™
ROCHESTER ELECTRO-MEDICAL, INC. · Model 016391 · UDI-DI 10816843024311
IKT
Prescription
10
510(k) clearances
150
Adverse events
2
Recalls
39
Facilities
Description
TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-09 | Technomed Europe | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. |
| 2007-04-12 | Chalgren Enterprises Inc | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.