52 results
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35ms
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Sources: EU EUDAMED, US FDA
MATERNA MEDICAL
FDA registration
MATERNA MEDICAL·1 product·🇺🇸 United States
Milli Vaginal Dilator
FDA UDI
Materna Medical, Inc.·00196852819690·Vaginal Dilator
Milli Vaginal Dilator
FDA UDI
Materna Medical, Inc.·00860010488706·Vaginal Dilator
Milli Vaginal Dilator
FDA UDI
Materna Medical, Inc.·00195893413942·Vaginal Dilator
AMEDA EGNELL VACUUM PUMP
FDA Adverse Event
Death
·HOLLISTER, INC.·Product code HDB·October 16, 1998
Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 19, 2020
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 12, 2020
GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
FDA Recall
Terminated
·GE Medical Systems Information Technologies·Product code HGM·May 21, 2003
XTERNAL NEUROSTIMULATOR, UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·October 24, 2014
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·October 24, 2014
SPARE CUTTER F/GB304R/GB305R/GB308R
FDA Adverse Event
Injury
·AESCULAP AG·Product code HWE·September 26, 2019