289 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·November 5, 2003
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
FDA Enforcement
Class II
·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
FDA Enforcement
Class II
·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model¿ SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.
FDA Enforcement
Class II
·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019
Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.
FDA Recall
Terminated
·Zimmer Inc.·Product code GFG·September 30, 2005
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code GFG·March 15, 2017
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code GFG·March 15, 2017
Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12; METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A. Product Usage: custom dialysis prep kits
FDA Recall
Terminated
·Lee Medical International Inc·Product code FKG·August 15, 2011
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code GFG·March 15, 2017