21 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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