30 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 3, 2017
Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
AVID Medical QA Pack AV10654-10
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·February 21, 2018
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
FDA Enforcement
Class II
·Terminated·Cell Marque Corporation·June 7, 2017
Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·December 18, 2013
Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 6, 2017