14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033449042·
PRESSURE WIRE SENSOR, MODEL 12003/12303
FDA 510(k)
FDA Class 2
·Cardiovascular
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CD HORIZON LEGACY MINI SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 16, 2024
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·March 1, 2013
UNKNOWN DEPUY UNI FEMORAL COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 24, 2011
EASY LOAD INSERTER
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·March 13, 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
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012