BEUDAMED
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    SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HHM

    FDA UDI
    Oticon A/S·05707131257031·H160, BTE 13 WL 85 CNB HHM

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857562097·Dilator Size Dia. 14.4 mm

    RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOCKET-HEX Ø4/11 CANN F/AFN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·May 29, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 1, 2014

    PROPEX

    FDA Adverse Event
    Malfunction ·DENTSPLY MAILLEFER·Product code LQY·June 13, 2011

    SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code MAX·March 19, 2012

    Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 25, 2026

    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 13, 2018

    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 3, 2019

    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·November 1, 2023

    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·May 10, 2023

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 19, 2019

    GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16) 2088026-713; 17) 2088026-714; 18) 2088026-715; 19) 2088026-723; 20) 2088026-806; 21) 2088026-906; 22) 2088026-936; 23) 2088026-940; 24) 2088026-943; 25) 2088026-946; 26) 2088026-948; 27) 2088026-957; 28) 2088026-959; 29) 2088026-960; 30) 2088026-961; 31) 2088026-962; 32) 2088026-967; 33) 2088026-969; 34) 2088026-970; 35) 2088026-971; 36) 2088026-973; 37) 2088026-985; 38) 2088026-989; 39) 2088026-990; 40) 2088026-993; 41) 2088026-994; 42) 2089629-003; 43) 2100169-001; 44) 2100491-006; 45) 2100491-012; 46) 2102675-010; 47) 2102675-101; 48) 2102676-001; 49) 2104867-001; 50) 2104867-044; 51) 2104867-045; 52) 2111141-004; 53) 5826659-002; 54) 5826659-013; 55) 5826659-014; 56) 5826659-016; 57) 5826659-017; 58) 5826659-018; 59) 5826659-019; 60) 5826659-021; 61) 5826659-022; 62) 5826659-023; 63) 5826659-025; 64) 5826659-026; 65) 5826659-027; 66) 5826659-028; 67) 5826659-029; 68) 5826659-030; 69) 5826659-032; 70) 5826659-033; 71) K1220JWED; 72) K2042VJED.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025