FDA Device Intelligence
Home › Atos Medical AB › Provox LaryClip

Provox LaryClip

Atos Medical AB · Model 7669 · UDI-DI 07331791002687

CBH
10
510(k) clearances
827
Adverse events (21 deaths)
12
Recalls
144
Facilities

Description

The Provox LaryClip is used for extra support for LaryButton and LaryTube. The product consists of two parts, one that is attached to the patients’ skin on each side of the stoma and the other part is attached to the LaryButton or the LaryTube. The two parts are then connected by Velcro.

Recalls

DateFirmReason
2024-12-23Hollister IncorporatedHollister received reports of decreased skin barrier wear time which could can lead to tube migration
2024-12-23Hollister IncorporatedHollister received reports of decreased skin barrier wear time which could can lead to tube migration
2024-12-23Hollister IncorporatedHollister received reports of decreased skin barrier wear time which could can lead to tube migration
2024-12-23Hollister IncorporatedHollister received reports of decreased skin barrier wear time which could can lead to tube migration
2024-11-18MEDLINE INDUSTRIES, LP - NorthfieldComplaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh
2024-11-18MEDLINE INDUSTRIES, LP - NorthfieldComplaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh
2024-11-18MEDLINE INDUSTRIES, LP - NorthfieldComplaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh
2024-11-18MEDLINE INDUSTRIES, LP - NorthfieldComplaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh
2017-03-24Dale Medical Products, Inc.ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
2017-03-24Dale Medical Products, Inc.ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.

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 docs
Data 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.