331 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWY·February 26, 2020
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
FDA Enforcement
Class II
·Terminated·Progressive Medical Inc·November 7, 2012
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
FDA Enforcement
Class II
·Terminated·Pro-Med Instruments Gmbh·December 13, 2017
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
FDA Enforcement
Class II
·Terminated·Progressive Medical Inc·November 21, 2012
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
FDA Recall
Terminated
·Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany·Product code HBL·November 2, 2017
Sterile Sheath, product code SS01.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Remote Control Unit with Wire, product code RCW100.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Device Sterilization Tray, product code T300.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Program Memory Card, product code MCV1A.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned, product code i60SRC.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, Curved, product code iDriveC; Intelligent Delivery System, Flexible, product code iDriveF.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code RCPOR.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Power Supply -not sold separately, product code PWSP; Power Cord - Not sold separately, product code PWCD.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Power Console, product code PC100; Power Console System, product code PC100S; Power Console Reconditioned, product code PC100RC.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular Stapler 29 mm Digital Loading Unit, product code PCS29.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit, product code RALC30V; Right Angle Linear Cutter, 45 mm Digital Loading Unit, product code RALC45.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power Extender Straight with Integrated Controls Reconditioned, product code PES200RC.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply, product code iB1C1; Intelligent Battery Insertion Guide, product code iBIG-1; Intelligent Battery Insertion Tool, product code iBIT-1.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product code PLC75; Power Linear Cutter Reload, 75 mm Blue, product code PLCR75B; Power Linear Cutter Reload, 75 mm Green, product code PLCR75G.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009