BEUDAMED
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    ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Debakey Coarctation Clamp

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896122727·Debakey Coarctation Clamp Straight Atraumatic Jaw

    WELLACE STIFLE RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049178·WELLACE STIFLE RETRACTOR NEROMA STYLE TIPS

    EXTRACTION FORCEPS #89W MODIFIED WIDER BEAK

    FDA UDI
    W.H. Holden, Inc.·D928100635089W0·

    NA

    FDA UDI
    aap Implantate AG·04042409037191·Drill sleeve CS 3.5, I-ø3.6

    EXTRACTION FORCEPS UPPER WISDOM TOOTH #130 S-CURVE

    FDA UDI
    W.H. Holden, Inc.·D9281006351300·

    ZAVATION

    FDA UDI
    Zavation LLC·00842166189690·Drill, Angled 3.5mm

    EXTRACTION FORCEPS #90W MODIFIED WIDER BEAK

    FDA UDI
    W.H. Holden, Inc.·D928100635090W0·

    Monoblock Tibial Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042479·

    BD INSYTE-N AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FOZ·October 18, 2018

    MODIFICATION TO HP M2376A DEVICE LINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERLOK / HA COPELAND RESURFACING HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 24, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    WAVELIGHT FS200 FEMTOSECOND LASER

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·May 13, 2011

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 22, 2018

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 4, 2019

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 20, 2022

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022