127 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
FDA Enforcement
Class II
·Terminated·Allergan Inc·July 29, 2015
Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 298.838S; EXP (repackager), Synthes (OEM) Cerclage, fixation
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015
Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valleylab (OEM) Electrosurgical, cutting & coagulation & accessories
FDA Enforcement
Class II
·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015