10 results · 29ms · Sources: EU EUDAMED, US FDA

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LEGACY DENTAL IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

SCAPHIX, STAPLE, FIXATION, BONE

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO: HL168W TOUCH SCREEN

FDA 510(k)
FDA Class 2 ·Cardiovascular

SILCONE COATED I/A 45 HANDHELD INSTRUMENT

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·May 7, 2019

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·April 23, 2013

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2011

RIATA ST OPTIM ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

NORIAN DRILLABLE INJECT 10CC-STERILE

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MQV·February 7, 2018

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

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