BEUDAMED
    48 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·August 25, 2021

    728333 Spectral CT 7500 -Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·August 25, 2021

    Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·August 25, 2021

    728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·August 25, 2021

    728332 IQon Spectral CT-Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·August 25, 2021

    X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.

    FDA Enforcement
    Class II ·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020

    Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 28, 2013

    00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 28, 2013

    00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 28, 2013

    00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 28, 2013

    Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkaline battery to provide continuous 12-lead data recorded over a 24-hour period and a removable 24-hour compact flash (CF) card for data storage.

    FDA Enforcement
    Class II ·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020

    Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications.

    FDA Enforcement
    Class II ·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020

    ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.

    FDA Enforcement
    Class II ·Terminated·Zavation·June 9, 2021

    Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NEXGEN CEMENTED STEM EXT 598801813 NEXGEN CEMENTED STEM EXT 598801913 NEXGEN CEMENTED STEM EXT 598801610 NEXGEN FLUTED STEM EXT, 1 598801611 NEXGEN FLUTED STEM EXT, 1 598801612 NEXGEN FLUTED STEM EXT, 1 598801613 NEXGEN FLUTED STEM EXT, 1 598801614 NEXGEN FLUTED STEM EXT, 1 598801615 NEXGEN FLUTED STEM EXT, 1 598801616 NEXGEN FLUTED STEM EXT, 1 598801618 NEXGEN FLUTED STEM EXT, 1 598801619 NEXGEN FLUTED STEM EXT, 1 598801620 NEXGEN FLUTED STEM EXT, 2 598801622 NEXGEN FLUTED STEM EXT, 2 598801624 NEXGEN FLUTED STEM EXT, 2 597206126 NEXGEN MICRO ALL-POLY PAT 597206129 NEXGEN MICRO ALL-POLY PAT 597206132 NEXGEN MICRO ALL-POLY PAT 597206135 NEXGEN MICRO ALL-POLY PAT for use in total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.

    FDA Enforcement
    Class II ·Terminated·Arthrosurface, Inc.·February 18, 2015

    Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020