21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DRX - Ascend System
FDA UDI
CARESTREAM HEALTH, INC.·60889971021724·DRX-ASCEND SYSTEM/QG-50-4-R10-T600
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
FDA 510(k)
FDA Class 2
·Orthopedic
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TFNA SCREW 85MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·February 28, 2022
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 26, 2013
SKYTRON
FDA Adverse Event
MIZUKO·Product code GDC·March 3, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 31, 2011
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 11, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 11, 2013
OT SURESTEP ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 11, 2013
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 11, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 10, 2023
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 11, 2011
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·October 11, 2011
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 11, 2011
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 14, 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