BEUDAMED
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    GrandioSO Light Flow

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777662·LUMBAMED BASIC DORSAL STAYS M SILVER IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777617·LUMBAMED BASIC DORSAL STAY WM SILVER IV

    K-wire Sleeve

    FDA UDI
    Treace Medical Concepts, Inc.·00810111223898·4mm Long Sleeve

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159007770·Dennis Anastomosis Clamp

    BD MAX¿ CDIFF

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OZN·May 20, 2024

    BD MAX¿ CDIFF

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OZN·August 22, 2024

    MFCD 120

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOTION TRACKING

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 18, 2022

    USB CONVERTER- POLARIS SPECTRA CAMERA

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 10, 2016

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

    UNKNOWN HIP ACETABULAR CONSTRUCT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·May 27, 2026

    ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 DAVIE ROAD, FT. LAUDERDALE, FL 33317. RIO System - The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be approriate, and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·January 20, 2011

    MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code KQM·October 25, 2010

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014