12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLDERED POST KIT ARCHWIRE SS
FDA UDI
Ortho Arch Company Inc·D90911099017·.019x.025 RIGHT FORM SOLDERED POST Kit
NATRELLE INSPIRA COHESIVE BREAST IMPLANTS
FDA Adverse Event
Malfunction
·ALLERGAN, INC.·Product code FTR·April 1, 2022
ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMS SLING FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code FTL·May 8, 2013
MAXISKY 600
FDA Adverse Event
Malfunction
·BHM MEDICAL INC.·Product code FSA·April 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
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