12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
FDA 510(k)
FDA Class 2
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496032465·PERSONALITY 70 SHEER, SIZE 2XXL, CAMEL, GRADUAT...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032465·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm B...
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
FDA 510(k)
FDA Class 2
·Anesthesiology
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·March 29, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 25, 2011
PATIENT SPECIFIC FOSSA EMINENCE LEFT PROSTHESIS
FDA Adverse Event
Other
·TMJ IMPLANTS, INC.·Product code LZD·April 17, 2008
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017
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