21 results · 20ms · Sources: EU EUDAMED, US FDA

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T-SLING

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526827882·***DISC*LEVAMED ANKLE SUPPORT BLACK VI

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00505161·

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526827943·ACHIMED ACHILLES SUPP BLACK VI

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306800894·Lister Bandage Scissors, 18cm

GE LOGIQ 700

FDA 510(k)
FDA Class 2 ·Radiology

ADVANTA SST GRAFT (>_6MM)

FDA 510(k)
FDA Class 2 ·Cardiovascular

AEQ REV II GLENOID BASEPLATE DIA 25MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

FDA Enforcement
Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

ENDOVIVE 3S LOW PROFILE BALLOON KIT

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·January 11, 2016

MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 10, 2013

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 5, 2011

AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 25, 2024

D.4,5MM COMPRESSION SCREW L.32MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

D.4,5MM COMPRESSION SCREW L.23MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·May 21, 2024

EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

FDA Recall
Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015