52 results · 35ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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