67 results
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20ms
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Sources: EU EUDAMED, US FDA
Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 11, 2015
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
FDA Enforcement
Class II
·Terminated·Circadiance LLC·June 14, 2017
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
FDA Enforcement
Class III
·Terminated·Medtest Holdings, Inc.·May 24, 2017
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·July 27, 2016
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
N Latex CDT Kit
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·September 5, 2018
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·April 29, 2020
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·December 12, 2018
BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
FDA Enforcement
Class II
·Terminated·COVIDIEN MEDTRONIC·May 23, 2018