KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING— 510(k) K033453
Substantially EquivalentTyco Healthcare
FDA 510(k) clearance K033453 for KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING, Substantially Equivalent on 2004-04-29. Applicant: Tyco Healthcare. Device class: Unclassified.
Clearance details
- Applicant
- Tyco Healthcare
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code FRO
view allMore clearances from Tyco Healthcare
view all- K071049 — DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
- K070685 — KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
- K070653 — KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
- K061492 — MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
- K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.