10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032606·Baltic Denture System BDLoad Mw7 PLSEbim6DFm D3...
TILITE YG AND TILITE YGS
FDA 510(k)
FDA Class 1
·Physical Medicine
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
6.0MM TI PANGEA POLYAXIAL SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·March 23, 2011
EXTENSION PASSER ASSESSORY KIT
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·April 22, 2008
Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestrae 103, CH-8708 Mannedorf, Switzerland * Made in Germany. Blister 1 x 96 pcs.
FDA Recall
Terminated
·Tecan U S Inc·Product code JQW·April 11, 2005
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