65 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
FDA Enforcement
Class II
·Terminated·Restoration Robotics·November 27, 2013
LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210 (LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC PRT II US), B-2220 (LP-BND SYS, 10.0, STER, US), B-2225 (LAP-BND 10.0,ACCESS PORT II,US), B-2255 (LAP-BAND VG W/ACS PORT II (US), B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), B-2265 (LP-BND AP LG SYS, W/ACC PRT II); The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline.
FDA Recall
Terminated
·Allergan·Product code LTI·September 16, 2010
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
FDA Recall
Terminated
·Restoration Robotics·Product code ONA·October 13, 2013
Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03831-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·December 11, 2019
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-06, NDC #64054-3005-06, 5mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007