Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1062741

FEI Number

3000302153

Entity Name

SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)

City/State/Country

BIRMINGHAM, AL, US

Establishment Address

439 Industrial Ln, BIRMINGHAM, AL 35211, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093310

PMA Number

N/A

All Registered Proprietary Names

Microvascular Anastomotic Device Titanium Hemostatic Clip RiverLon (Nylon) Suture VTI Intraoperative Doppler Systems GEM ZIPCLIP GEM Biover Clamps None None DermaClose Continous External Tissue Expander DermaClose XL Continuous External Tissue Expander Forceps GEM Flow Coupler Device and System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVR	Device, Anastomotic, Microvascular	General, Plastic Surgery	Class 2	878.4300	2015-12-07
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2015-12-07
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2015-12-07
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2015-12-07
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-02-18
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2023-12-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-08
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	1991-04-01
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2017-12-22
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2015-12-07
MVR	Device, Anastomotic, Microvascular	General, Plastic Surgery	Class 2	878.4300	2015-12-07
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2015-12-07

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903633	Transonic Systems, Inc.	ADVANCE LASER FLOWMETER, ALF 21	1990-10-09
K182494	Laser Associated Sciences, Inc.	FlowMet-R	2019-02-27
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
2183744	Isomedix Operations, Inc.	Minneapolis, MN, US
2183967	Spectrum Plastics Group	Saint Louis Park, MN, US
3014461810	BURAK GLOBAL IC VE DIS TIC LTD STI	Kocasinan Kayseri, TR
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1062741. Last updated year: 2026. Please use registration number 1062741 when referencing this establishment in official correspondence.