216 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code FMZ·June 30, 2021
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·August 25, 2021
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 3, 2013
VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·October 22, 2010
VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·October 22, 2010
Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·October 22, 2010
Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·October 22, 2010
Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
FDA Recall
Terminated
·Product code JWH·February 22, 2010
XiO Radiation Treatment Planning System, Release 4.51.00.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·February 22, 2010
iBOT 4000 Mobility System Battery pack.
FDA Recall
Terminated
·Independence Technology LLC·Product code IMK·February 22, 2010
PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
FDA Recall
Terminated
·Medtest Holdings, Inc.·Product code JHW·November 22, 2010
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·April 22, 2010
Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" Origen DBM with Bioactive Glass Catalog #: 22-2002 (2cc size) 22-2005 (5cc size) 22-2010 (10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
FDA Recall
Terminated
·Nanotherapeutics, Inc·Product code MQV·March 10, 2011
Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni 9 Bussolengo (Verona) Italy·Product code JDW·February 22, 2010
Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni 9 Bussolengo (Verona) Italy·Product code JDW·February 22, 2010
The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal.
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code KYI·July 12, 2010
Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
FDA Recall
Terminated
·Transenterix, INC·Product code GCJ·June 22, 2010
The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal.
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code KYI·July 12, 2010
Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010