Home › Jiangsu Vedkang Medical Science and Technology Co.,Ltd. › VedDilator; 3-Stage Balloon Dilation Catheter

VedDilator; 3-Stage Balloon Dilation Catheter

Jiangsu Vedkang Medical Science and Technology Co.,Ltd. · Model VDK-TBD-15/16.5/18-80-120 · UDI-DI 06941513203646

KNQ Prescription

510(k) clearances

5,261

Adverse events (16 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18	Diversatek Healthcare	The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2013-05-28	Boston Scientific Corporation	Product labeled with incorrect expiration date.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16	Conmed Endoscopic Technologies, Inc.	Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

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 key Read 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.