13 results · 22ms · Sources: EU EUDAMED, US FDA

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CORE-FLO D/C

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO M2376A DEVICELINK SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870

FDA 510(k)
FDA Class 2 ·General Hospital

VERCISE CARTESIA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 12, 2023

PLMA DVC C11.51 1 N

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 26, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 18, 2011

PINNACLE SECTOR II CUP 52MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 5, 2010

PINNACLE MTL INS NEUT 36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 5, 2010

S-ROM M HEAD 36MM +6

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 5, 2010

Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

FDA Enforcement
Class I ·Terminated·Stryker Spine·August 28, 2013

MDLR CNLTD TRIDRV DRVR

FDA Adverse Event
Malfunction ·EXACTECH, INC.·Product code LXH·August 29, 2023

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