Innovatech Medical Resources L.P.
Midlothian, TX
Innovatech Medical Resources L.P. appears in FDA device records in Midlothian, TX. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 21 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 21
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0628-2012 | OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0627-2012 | 5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0626-2012 | 3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0625-2012 | 90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0624-2012 | Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0623-2012 | Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic proce | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0622-2012 | Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0621-2012 | 3.5mm 90 Degree Part Number A1335-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0620-2012 | 3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0619-2012 | CoVac 70 Product Number AS3730-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in arthroscopic procedures. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0618-2012 | CoVac 50 Product Number AS2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0617-2012 | MultiVac Tristar 50 Product Number AS4630-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0616-2012 | SideWinder Hip Wand Product Number AC2340-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0615-2012 | 3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0614-2012 | OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0613-2012 | OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0612-2012 | OPUS SmartStitch Product Number OM-8178 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0611-2012 | OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0610-2012 | OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0609-2012 | OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator cuff repair. | Product is being removed from the field due to an over-label issue. | Terminated | ||
| Z-0608-2012 | OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder. | Product is being removed from the field due to an over-label issue. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
