20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
FDA 510(k)
FDA Class 2
·Cardiovascular
DOVER RED RUBBER ROBINSON CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Specimen Retrieval Bag
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERGARD KNITTED VASCULAR PROSTHESIS
FDA Adverse Event
Injury
·INTERVASCULAR·Product code DSY·November 4, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
7.3MM CANNULATED SCREW 16MM THREAD/100MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 22, 2013
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 2, 2024
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 2, 2024
UNKNOWN_CORK_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·March 14, 2014
TECNIS MULTIFOCAL
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code MFK·July 27, 2021
TECNIS SYMFONY
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code POE·July 27, 2021
UNK - IMPLANTS - VERSALOK
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HWC·October 24, 2019
UNK - IMPLANTS
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·October 24, 2019
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 30, 2018
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 30, 2018
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·August 7, 2013
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025