25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITEK 2 GRAM POSITIVE MEROPENEM
FDA 510(k)
FDA Class 2
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI
Neo-Tee T-Piece Resuscitator
FDA UDI
MERCURY ENTERPRISES, INC.·10641043508169·
Tandem Locks, CT/MR
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020925·
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·December 28, 2006
DENTO-PREP PARTICLE MICROBLASTER
FDA 510(k)
FDA Class 2
·Dental
SHARP BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·November 22, 2006
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
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·March 15, 2007
EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) 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
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 10, 2013
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
TITAN MODULAR TOTAL SHOULDER SYSTEM - HEAD
FDA Adverse Event
Injury
·ASCENSION ORTHOPEDICS, INC.·Product code KWS·April 1, 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