ENDO-BEND(TM) SHAVER— 510(k) K950054
Substantially EquivalentPaladin Medical, Inc.
FDA 510(k) clearance K950054 for ENDO-BEND(TM) SHAVER, Substantially Equivalent on 1995-06-29. Applicant: Paladin Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Paladin Medical, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
Recent devices under product code HRX
view allMore clearances from Paladin Medical, Inc.
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- K970347 — MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
- K971290 — STRATASYS FDM MEDMODELER SYSTEM
- K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
- K935220 — CORE PREVENT MATTRESS MODIFICATION
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.