17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00610191·
STRAIGHT PLATE, 19-HOLE
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029079·
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610191·Mini Sprint-Brackets 5-5 Roth .022" 400 Brackets
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI500 GLOBE-TROTTER TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BIOMET G7 LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·March 16, 2018
BIOMET G7 LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·March 16, 2018
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 21, 2008
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·April 16, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 18, 2011
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL·Product code HQL·June 13, 2008
MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·October 20, 2010
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 22, 2011
HOSP SS FLEXX METER W/O LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Death
·LIFESCAN INC.·Product code NBW·April 1, 2011
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