18 results · 27ms · Sources: EU EUDAMED, 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