24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
FDA 510(k)
FDA Class 2
·Orthopedic
3M™ Unitek™ SmartClip™ MBT™
FDA UDI
3m do Brasil Ltda.·00652221003881·SmartClip(TM) Self-Ligating Bracket MBT(TM) LR4...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0430200·Sagittal Bender, Double Ended Left
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107614·METZENBAUM SCISSORS, 8", SLIM DELICATE, STR
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
FDA 510(k)
FDA Class 2
·Anesthesiology
CHEMWELL, ALSO KNOWN AS PROJECT 2900
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FRN·March 13, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 15, 2011
VITALITY DS
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016