49 results
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16ms
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Sources: EU EUDAMED, US FDA
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 24, 2024
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 18, 2018
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 18, 2018
CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.
FDA Enforcement
Class II
·Terminated·Med Tec Inc·September 6, 2017
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 18, 2018
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 18, 2018
CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..
FDA Enforcement
Class II
·Terminated·Med Tec Inc·September 6, 2017
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 16, 2025
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025