BEUDAMED
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    DENTAL CHEWING GUM (SUGARLESS)

    FDA 510(k)
    FDA Class 1 ·Dental

    GL GoodLife Blood Glucose Test Strip-Foil For Cloudia

    FDA UDI
    HMD BIOMEDICAL INC.·00389154000266·GL GoodLife Blood Glucose Test Strip-Foil For C...

    GL GoodLife

    FDA UDI
    HMD BIOMEDICAL INC.·00389154000372·GL GoodLife Blood Glucose Monitoring System(Clo...

    PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID

    FDA 510(k)
    FDA Class 2 ·Dental

    DAUM DOUBLE-SHOOT BISOPSY GUN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

    PALAXPRESS, CLEAR, 1000G POWDER

    FDA Adverse Event
    Injury ·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014

    HS HAND CONTROLLED CURVED SHEA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GEI·November 12, 2007

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·October 23, 2012

    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·December 5, 2018

    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·June 19, 2018

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024