12 results · 22ms · Sources: EU EUDAMED, 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