17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
My Medical
FDA UDI
My Medical Store LLC·G4251106630·Deaver Retractor Fiberoptic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817021·Deaver Retractor with Light, Blade Size: (1.6 c...
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
FDA 510(k)
FDA Class 2
·Cardiovascular
FIBULA COMP LOCK PLATE 10H STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 24, 2016
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021
CORONOID PLATE RT STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·June 9, 2016
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 1, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
S3 SHOULDER PLATE 4 HOLE RIGHT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021