18 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLOOD PRESSURE MONITOR, MODEL KP-7000
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032492·Baltic Denture System BDLoad Mw6 PLSEbim6DFm C1...
ACE SurgicalSilk Bb 4-0 18" Dsm13
FDA UDI
Surgical Specialties México, S. de R.L. de C.V.·00848782022854·003-2492 Silk Bb 4-0 18" Dsm13
KADANCE 2000
FDA 510(k)
FDA Class 2
·Orthopedic
SIMPLICITY SOFT INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
9611993-2022-032492
FDA Adverse Event
Injury
·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·January 11, 2022
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 29, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 23, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Other
·EDWARDS LIFESCIENCES·Product code KRH·April 16, 2008
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005
Torcon NB
FDA UDI
COOK INCORPORATED·00827002310704·Torcon NB, Advantage Catheter
SELEX/MAGNUM MOD HD 40MM +9
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·April 24, 2014
TI LOW PROFILE SCREW 6.5X20MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
TI LOW PROFILE SCREW 6.5X20MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
REGEN/RNGLC+ MULTI 64MM SZ 26
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016