18 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIPHYSIS SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
3M™ Unitek™ SmartClip™ MBT™
FDA UDI
3m do Brasil Ltda.·00652221003867·SmartClip(TM) Self-Ligating Bracket MBT(TM) LL4...
VERNACARE CANADA, INC.
FDA registration
VERNACARE CANADA, INC.·5 products·🇨🇦 Canada
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm
PC
FDA UDI
Allied Medical, LLC·00026072013137·ADAPTER,M*S,QC TO DS ML WAGD
AT HOME DRUG TEST, MODEL 9064
FDA 510(k)
FDA Unclassified
·Unknown
CONCENTRIC RETRIEVER, MODEL 90030
FDA 510(k)
FDA Class 2
·Cardiovascular
EPD 60000 RPM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·March 11, 2013
MARQUIS SERIES STOPCOCKS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·February 25, 2011
VITALITY DR HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZI·September 3, 2013
CABLE 3M TO CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Injury
·COOK INC·Product code EZN·May 21, 2019
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" 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
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012