Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010348

FEI Number

1000251124

Entity Name

TALLEY GROUP LTD.

City/State/Country

ROMSEY, HANTS. Hampshire, GB

Establishment Address

PREMIER WAY,, ABBEY PARK INDUSTRIAL ESTATE, ROMSEY, HANTS. Hampshire SO51 9AQ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TALLEY GROUP LTD. (Owner Number: 8010348)

Owner / Operator Contact Address

PREMIER WAY,, ABBEY PARK INDUSTRIAL ESTATE, ROMSEY, HANTS., GB-NOTA SO51 9AQ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151263

PMA Number

N/A

All Registered Proprietary Names

Venturi Venturi MiNO TG600/14 Venturi NPWT v.11 Advanced vacuum system TALLEY RIPPLEBED PUMP- PULSAIR PAD DUO CARE POWER UNIT NPWT Dressings Venturi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2009-11-30
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2016-09-16
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2013-11-08
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	1978-02-15
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2016-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

Miriam Walls Business: XFDA Inc Email: mwalls@xfda.com Phone: (703) 9195372

Related Public Records

Same Entity

TALLEY GROUP LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010348. Last updated year: 2026. Please use registration number 8010348 when referencing this establishment in official correspondence.