151 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.
FDA Enforcement
Class II
·Terminated·Estill Medical Technologies, Inc·October 29, 2014
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 5, 2022
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·June 1, 2022
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·March 9, 2016
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·March 9, 2016
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·March 9, 2016
50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·March 9, 2016
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
FDA Enforcement
Class II
·Terminated·Leventon S. A. U.·September 4, 2019
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.
FDA Enforcement
Class II
·Terminated·Ziemer Usa Inc·January 29, 2014