FDA Device Registration & Listing · Charlotte, NC, US · Registration 3011324393
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-02-12 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2025-02-12 |
| KGS | Retention Device, Suture | General, Plastic Surgery | Class 1 | 878.4930 | 2025-02-12 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | Unknown | Class 3 | N/A | 2025-02-12 |
| QSK | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment | Unknown | Class 3 | N/A | 2025-02-12 |
| SEQ | Covered Stent Vascular Connector, Hemodialysis Access Circuit | Unknown | Class 3 | N/A | 2025-08-20 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2025-05-23 |
| QXR | Vaginal Hydrogel Packing System | Radiology | Class 2 | 892.5735 | 2025-02-12 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1223009 | MDI East, Inc., dba Medefab | JAFFREY, NH, US |
| 3006686250 | Guangzhou Schauenburg-Truplast Hose Technology Ltd. | Guangzhou Guangdong, CN |
| 3015146495 | MOLDED DEVICES, INC. | Tempe, AZ, US |
| 8022265 | GLOBALMED, INC. | TRENTON Ontario, CA |
| 1321175 | BATES INDUSTRIES | S Glens Falls, NY, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K193295 | Parcus Medical, LLC | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | 2020-01-23 |
| K193606 | Conmed Corporation | Y-Knot OneStep Anchor | 2020-01-22 |
| K984200 | R. Thomas Grotz, M.D., Inc. | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE | 1999-01-21 |
| K171060 | Riverpoint Medical | OrthoButton AL | 2017-06-02 |
| K231867 | Paragon 28, Inc. | Grappler Suture Anchor System | 2023-08-21 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0006-2019 | N/A | 3 | ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF:
BA22-120/I20-40,
BA22-100/I20-40,
BA22-80/I20-40,
BA22-60/I20-40,
BA22-40/I20-40,
BA22-120/I16-40,
BA22-100/I16-40,
BA22-80/I16-40,
BA22-60/I16-40,
BA22-40/I16-40,
BA22-120/I13-40,
BA22-100/I13-40,
BA22-80/I13-40,
BA22-60/I13-40,
BA22-40/I13-40,
BA22-110/I20-30,
BA22-90/I20-30,
BA22-70/I20-30,
BA22-50/I20-30,
BA22-110/I16-30,
BA22-90/I16-30,
BA22-70/I16-30,
BA22-50/I16-30,
BA22-100/I20-55,
BA22-80/I20-55,
BA22-100/I16-55,
BA22-80/I16-55,
BA25-120/I20-40,
BA25-100/I20-40,
BA25-80/I20-40,
BA25-60/I20-40,
BA25-40/I20-40,
BA25-120/I16-40,
BA25-100/I16-40,
BA25-80/I16-40,
BA25-60/I16-40,
BA25-40/I16-40,
BA25-120/I13-40,
BA25-100/I13-40,
BA25-80/I13-40,
BA25-60/I13-40,
BA25-40/I13-40,
BA25-110/I20-30,
BA25-90/I20-30,
BA25-70/I20-30,
BA25-50/I20-30,
BA25-110/I16-30,
BA25-90/I16-30,
BA25-70/I16-30,
BA25-50/I16-30,
BA25-100/I20-55,
BA25-80/I20-55,
BA25-100/I16-55,
BA25-80/I16-55,
BA28-120/I20-40,
BA28-100/I20-40,
BA28-80/I20-40,
BA28-60/I20-40,
BA28-40/I20-40,
BA28-120/I16-40,
BA28-100/I16-40,
BA28-80/I16-40,
BA28-60/I16-40,
BA28-40/I16-40,
BA28-120/I13-40,
BA28-100/I13-40,
BA28-80/I13-40,
BA28-60/I13-40,
BA28-40/I13-40,
BA28-110/I20-30,
BA28-90/I20-30,
BA28-70/I20-30,
BA28-50/I20-30,
BA28-110/I16-30,
BA28-90/I16-30,
BA28-70/I16-30,
BA28-50/I16-30,
BA28-100/I20-55,
BA28-80/I20-55,
BA28-100/I16-55,
BA28-80/I16-55 |
| Z-0007-2019 | N/A | 3 | ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF:
BEA22-120/I20-40,
BEA22-100/I20-40,
BEA22-80/I20-40,
BEA22-60/I20-40,
BEA22-40/I20-40,
BEA22-120/I16-40,
BEA22-100/I16-40,
BEA22-80/I16-40,
BEA22-60/I16-40,
BEA22-40/I16-40,
BEA22-120/I13-40,
BEA22-100/I13-40,
BEA22-80/I13-40,
BEA22-60/I13-40,
BEA22-40/I13-40,
BEA22-110/I20-30,
BEA22-90/I20-30,
BEA22-70/I20-30,
BEA22-50/I20-30,
BEA22-110/I16-30,
BEA22-90/I16-30,
BEA22-70/I16-30,
BEA22-50/I16-30,
BEA22-100/I20-55,
BEA22-80/I20-55,
BEA22-100/I16-55,
BEA22-80/I16-55,
BEA25-120/I20-40,
BEA25-100/I20-40,
BEA25-80/I20-40,
BEA25-60/I20-40,
BEA25-40/I20-40,
BEA25-120/I16-40,
BEA25-100/I16-40,
BEA25-80/I16-40,
BEA25-60/I16-40,
BEA25-40/I16-40,
BEA25-120/I13-40,
BEA25-100/I13-40,
BEA25-80/I13-40,
BEA25-60/I13-40,
BEA25-40/I13-40,
BEA25-110/I20-30,
BEA25-90/I20-30,
BEA25-70/I20-30,
BEA25-50/I20-30,
BEA25-110/I16-30,
BEA25-90/I16-30,
BEA25-70/I16-30,
BEA25-50/I16-30,
BEA25-100/I20-55,
BEA25-80/I20-55,
BEA25-100/I16-55,
BEA25-80/I16-55,
BEA28-120/I20-40,
BEA28-100/I20-40,
BEA28-80/I20-40,
BEA28-60/I20-40,
BEA28-40/I20-40,
BEA28-120/I16-40,
BEA28-100/I16-40,
BEA28-80/I16-40,
BEA28-60/I16-40,
BEA28-40/I16-40,
BEA28-120/I13-40,
BEA28-100/I13-40,
BEA28-80/I13-40,
BEA28-60/I13-40,
BEA28-40/I13-40,
BEA28-110/I20-30,
BEA28-90/I20-30,
BEA28-70/I20-30,
BEA28-50/I20-30,
BEA28-110/I16-30,
BEA28-90/I16-30,
BEA28-70/I16-30,
BEA28-50/I16-30,
BEA28-100/I20-55,
BEA28-80/I20-55,
BEA28-100/I16-55,
BEA28-80/I16-55 |
| Z-0008-2019 | N/A | 3 | ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO,
AFX Proximal Accessory,
Infrarenal Model #/REF:
A22-22/C55,
A22-22/C75,
A22-22/C95,
A25-25/C55,
A25-25/C75,
A25-25/C95,
A28-28/C55,
A28-28/C75,
A28-28/C95,
A31-31/C80,
A31-31/C100,
A34-34/C80,
A34-34/C100;
Suprarenal Model #/REF:
A22-22/C55-O20,
A22-22/C75-O20,
A22-22/C95-O20,
A25-25/C55-O20,
A25-25/C75-O20,
A25-25/C95-O20,
A28-28/C55-O20,
A28-28/C75-O20,
A28-28/C95-O20,
A31-31/C80-O20,
A31-31/C100-O20,
A34-34/C80-O20,
A34-34/C100-O20;
AFX Vela,
Infrarenal Model #/REF:
A22-22/C55V,
A22-22/C75V,
A22-22/C95V,
A25-25/C55V,
A25-25/C75V,
A25-25/C95V,
A28-28/C55V,
A28-28/C75V,
A28-28/C95V,
A31-31/C80V,
A31-31/C100V,
A34-34/C80V,
A34-34/C100V;
Suprarenal Model #/REF:
A22-22/C55-O20V,
A22-22/C75-O20V,
A22-22/C95-O20V,
A25-25/C55-O20V,
A25-25/C75-O20V,
A25-25/C95-O20V,
A28-28/C55-O20V,
A28-28/C75-O20V,
A28-28/C95-O20V,
A31-31/C80-O20V,
A31-31/C100-O20V,
A34-34/C80-O20V,
A34-34/C100-O20V |
| Z-0009-2019 | N/A | 3 | ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF:
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F,
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F;
AFX Stand Alone
I16-16/C55 SA,
I16-16/C55F SA,
I16-16/C88 SA,
I20-13/C70F SA,
I20-13/C88F SA,
I20-20/C55 SA,
I20-20/C55F SA,
IS20-25/C55 SA,
IF20-25/C65 SA,
IS20-25/C65 SA |
| Z-0043-2026 | Cook Medical Incorporated | 3 | Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2-
Reference Part Numbers
ZTA2-P-40-117-W
ZTA2-P-40-167
ZTA2-P-40-167-W
ZTA2-P-40-217-W
ZTA2-P-42-121
ZTA2-P-42-121-W
ZTA2-P-42-173
ZTA2-P-42-173-W
ZTA2-P-42-225
ZTA2-P-42-225-W
ZTA2-P-44-125
ZTA2-P-44-125-W
ZTA2-P-44-179
ZTA2-P-44-179-W
ZTA2-P-44-233
ZTA2-P-44-233-W
ZTA2-P-46-125
ZTA2-P-46-125-W
ZTA2-P-46-179
ZTA2-P-46-179-W
ZTA2-P-46-233-W
ZTA2-PT-40-36-167
ZTA2-PT-40-36-167-W
ZTA2-PT-40-36-217
ZTA2-PT-40-36-217-W
ZTA2-PT-42-38-173
ZTA2-PT-42-38-173-W
ZTA2-PT-42-38-225
ZTA2-PT-42-38-225-W
ZTA2-PT-44-40-179
ZTA2-PT-44-40-179-W
ZTA2-PT-44-40-233-W
ZTA2-PT-46-42-179
ZTA2-PT-46-42-179-W
ZTA2-PT-46-42-233
ZTA2-PT-46-42-233-W
ZTA2-P-46-233
ZTA2-PT-44-40-233
ZTA2-P-40-217
ZTA2-P-40-117
ZTA2-P-40-167-DEMO
ZTA2-P-44-152-W
ZTA2-P-40-142
ZTA2-P-44-152
ZTA2-P-40-142-W |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1219930 | Covidien | North Haven, CT, US |
| 3016660811 | SUBCHONDRAL SOLUTIONS | Costa Mesa, CA, US |
| 1054811 | Sterigenics U.S. LLC | MULBERRY, FL, US |
| 3016851379 | Arthrex Distribution Hub EMEA B.V. | Venlo Limburg, NL |
| 3011989923 | DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI | Istanbul, TR |
3011324393 when referencing this establishment in official correspondence.