11 results
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18ms
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Sources: EU EUDAMED, US FDA
OSCILLOMETRIC PULSE DETECTION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
ERA ANGLE 3.25MM IMP MICRO HEAD 10X3MM ACID ETCHED, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109614·Designed for both transitional and long-term de...
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
FDA 510(k)
FDA Class 2
·Microbiology
FLEXI-SEAL CONTROL FMS KIT US
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·May 7, 2014
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·January 8, 2013
JAMSHIDI NEEDLE BONE MARROW 11GX6 ASP
FDA Adverse Event
Injury
·CAREFUSION·Product code FSH·October 15, 2010
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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