SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)

FDA Device Registration & Listing · Saint Paul, MN, US · Registration 2183620

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2183620
FEI Number
2183620
Entity Name
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)
City/State/Country
Saint Paul, MN, US
Establishment Address
2575 University Ave W, Saint Paul, MN 55114, US
Establishment Type(s)
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
N
Expiration Date (Year)
2026
510(k) Number
K192615
PMA Number
N/A

All Registered Proprietary Names

GEM Biover Clamps Peri-Strips Dry with Veritas Flo-Thru Vascu-Guard Vascular Repair Patch Vascular Probe Veritas Collagen Matrix Flo-Rester Vascu-Guard Peri-Guard, Supple Peri-Guard Flo-Rester Vessel Sizer Peri-Strips Dry with Veritas PERI-GUARD Repair Patch, Supple PERI-GUARD Repair Patch Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Techonology (PSDV-SG)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2023-12-05
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2015-01-22
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2015-01-22
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2022-11-11
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2015-01-22
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2015-01-22
PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2015-01-22
OXB Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction General, Plastic Surgery Class 2 878.3300 2015-01-22
OXE Mesh, Surgical, Collagen, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2015-01-22
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2015-01-22
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2015-01-22
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2015-01-22
OXB Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction General, Plastic Surgery Class 2 878.3300 2015-01-22
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2015-01-22
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2015-01-22
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2023-04-28
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2019-12-20
OXE Mesh, Surgical, Collagen, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2019-12-20

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
K134033 Miromatrix Medical, Inc. MIROMATRIX BIOLOGICAL MESH 2014-03-31
K810894 American Edwards Laboratories FOGARTY FLEXIBLE CALIBRATOR 1981-05-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2020 AZIYO BIOLOGICS 2
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020 AZIYO BIOLOGICS 2
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183620. Last updated year: 2026. Please use registration number 2183620 when referencing this establishment in official correspondence.
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