11 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOLOC SPS Shoulder Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
FDA 510(k)
FDA Class 2
·Cardiovascular
PROPATCH SOFT TISSUE REPAIR MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 25, 2024
MEDFUSION
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·January 9, 2023
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS .·Product code LFR·September 25, 2008
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
GMK-HINGE FIXED TIBIAL TRAY SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·April 7, 2020
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016