18 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSX·February 3, 2017
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033363·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...
CROSSPOINT TRANSACCESS CATHETER
FDA 510(k)
FDA Class 2
·Radiology
M2A 32MM TAPER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014
PROSTHESIS, HIP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021
D903 DIDECO AVANT 2 VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014
IT PADOVA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013
D903 DIDECO AVANT VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 3, 2013
DYNAMIC COMPRESSION SMA STAPLE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·March 30, 2011
ACRYSOF TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH LTD / HUNTINGTON·Product code HQL·April 24, 2008
C20441 IL HAIFA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·March 28, 2012
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013