17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREEDOM MARK III SURGICAL HELMET SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827875·***DISC*LEVAMED ANKLE SUPPORT BLACK V
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909105152·REVELATION DIAMOND 845-014C - 5 PACK
STABILITY
FDA UDI
Stryker GmbH·00886385022499·Radial Insert Tool, SM
MODIFICATION TO SYNERGY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UCP DRUG SCREENING TEST CUPS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·November 19, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 2, 2014
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code MKJ·November 30, 2012
BD DISCARDIT II 10 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 10, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 12, 2019
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 23, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 24, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 13, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 16, 2019
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024