20 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 2, 2018
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·January 1, 2020
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·April 4, 2018
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·April 4, 2018
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
FDA Enforcement
Class II
·Terminated·Abbott Medical·January 15, 2020
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 13, 2021
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022