60 results
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18ms
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Sources: EU EUDAMED, US FDA
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REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·May 24, 2018
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
FDA Recall
Terminated
·Reckitt Benckiser LLC·Product code MOL·August 6, 2018
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code JDR·August 6, 2013
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
FDA Recall
Terminated
·Crossroads Extremity Systems Llc·Product code JDR·February 16, 2017