18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MegaGen Dental Implant Systems Portfolio - MR Conditional
FDA 510(k)
FDA Class 2
·Dental
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318119·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...
SFI-ANCHOR
FDA 510(k)
FDA Class 2
·Dental
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code BSP·November 21, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM
FDA Adverse Event
Injury
·STRYKER TRAUMA SELZACH·Product code KTT·November 6, 2014
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 16, 2013
ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 5, 2023
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·May 15, 2024
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020