13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUTURABOND NR
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074033174·BONE SCREW 7042670 20 DEG ILC 6.5X70 TI
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867558·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
BOSS 2000-3 VACUUM ERECTION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TARGETING ARM PROX. LAT TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
BDRV CANN SCW SS P/T DIA4.5X60MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017
BDRV CANN SCW SS P/T DIA4.5X52MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017
12.4CM HEAVY DUT LONG ATTCH
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBE·April 2, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 6, 2011
INSIGNIA ULTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
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