17 results · 23ms · Sources: EU EUDAMED, 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