BEUDAMED
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    Disposable Standard Clamp

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

    TPRLC 133 FP TYPE1 PPS HO 5.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·May 31, 2018

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021

    AIR-N-GO

    FDA 510(k)
    FDA Class 1 ·Dental

    PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S

    FDA 510(k)
    FDA Class 2 ·Dental

    TPRLC 133 FP TYPE1 PPS HO 5.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·May 31, 2018

    TPRLC 133 FP TYPE1 PPS HO 5.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·May 31, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 24, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 20, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 10, 2008

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·December 30, 2025

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·June 10, 2025

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code NKB·January 22, 2026

    POLIGRIP CUSHION COMFORT

    FDA Adverse Event
    Injury ·ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH·Product code KOT·July 6, 2020

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026