Data / Medical devices / Italy / Dambo SRL

Dambo SRL: FDA-registered device maker in Putignano Bari, Italy, 2 510(k) clearances and 5 PMA approvals

Name: Dambo SRL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dambo SRL is registered with the FDA (registration 3031983053) in Putignano Bari, Italy. It lists 6 device types. The FDA files 2 510(k) clearances and 5 PMA approvals under its listings, the newest dated December 18, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Dambo SRL

FDA registration number: 3031983053
Address: Via Maestri Del Lavoro, Putignano Bari, Italy, 70017
Owner or operator: Dambo SRL (10091247)
Roles: Exporter to the US, Repackager or relabeler
First device listed: July 31, 2024
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Acid, Hyaluronic, Intraarticular	MOZ	3	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use	LMH	3	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use In The Hands	PKY	3	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Introducer, Catheter	DYB	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 18, 2020	K201075	BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter	FOZ	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 19, 2016	K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 29, 2017	P170007	DUROLANE	MOZ	15	December 23, 2025	accessdata.fda.gov
February 25, 2014	P090031	MONOVISC	MOZ	15	August 8, 2023	accessdata.fda.gov
December 22, 2006	P050052	RADIESSE INJECTABLE IMPLANT	LMH	169	June 26, 2026	accessdata.fda.gov
December 3, 2004	P010029	EUFLEXXA (1% SODIUM HYALURONATE)	MOZ	40	September 2, 2026	accessdata.fda.gov
January 24, 2001	P980044	SUPARTZ FX	MOZ	62	September 4, 2026	accessdata.fda.gov

Compare with other makers

Updated December 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.