13 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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EMBRACE WETBOND CLEAR SEALANT
FDA 510(k)
FDA Class 2
·Dental
ConMed
FDA UDI
Provision·B504OM50522810·
CONMED
FDA UDI
Conmed Corporation·10845854002025·RECIPROCATOR BLADE, 9.4 X 54.5 X 1.5 MM
BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 21, 2023
TRS-2000 POWER TILT/POWER RECLINE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
STELKAST PROVEN KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 31, 2010
UNKNOWN HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 25, 2017
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 11, 2013
HEARTMATE XVE
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·April 12, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 23, 2008
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