19 results
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26ms
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Sources: EU EUDAMED, US FDA
MICROMATE 196 MODEL A961960
FDA 510(k)
FDA Class 1
·Microbiology
Stern EX Acid Etched Implant RP 4.0x11.5mm, with cover screw, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109034·The Sterngold Acid Etch Dental Implant System c...
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404901808·Straight Drill
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019924863·ALIF Sizer 8 degree 21mm x 39mm
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019924825·ALIF Sizer 8 degree 13mm x 39mm
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019924856·ALIF Sizer 8 degree 19mm x 39mm
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019924832·ALIF Sizer 8 degree 15mm x 39mm
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019924818·ALIF Sizer 8 degree 11mm x 39mm
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019924849·ALIF Sizer 8 degree 17mm x 39mm
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019924801·ALIF Sizer 8 degree 9mm x 39mm
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
FDA 510(k)
FDA Class 2
·Cardiovascular
DORO HEADREST SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523142255·Tesera X Trial, 60mm x 18mm x 8mm x 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523141999·Tesera X Trial, 60mm x 18mm x 8mm x 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523141739·Tesera X Trial, 60mm x 18mm x 8mm x 0°
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014
TI PANGEA(TM) LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·January 8, 2013
LOW PROFILE SELF-TAPPING BONE SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 17, 2010
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