46 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
FDA Recall
Terminated
·Radiometer America Inc·Product code LPP·November 27, 2012
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
FDA Enforcement
Class II
·Terminated·App Pharmaceuticals Llc·June 27, 2012
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
FDA Enforcement
Class II
·Terminated·App Pharmaceuticals Llc·June 27, 2012
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.
FDA Enforcement
Class II
·Terminated·Pajunk Medical Systems, L.P.·November 30, 2022
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
FDA Recall
Terminated
·App Pharmaceuticals Llc·Product code NZW·May 20, 2010
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
FDA Recall
Terminated
·App Pharmaceuticals Llc·Product code NZW·May 20, 2010
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
FDA Enforcement
Class II
·Terminated·LAP of America Laser Applications, LLC·June 11, 2014
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
FDA Enforcement
Class II
·Terminated·LAP of America Laser Applications, LLC·July 2, 2014
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
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·August 8, 2011
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.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011
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.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011
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.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code GAT·August 8, 2011
5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
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.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011
OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator cuff repair.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code HWC·August 8, 2011
3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011
OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011
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.
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011