14 results
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21ms
·
Sources: EU EUDAMED, US FDA
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAM®
FDA UDI
LSI Solutions, Inc.·00850200006667·RAM® DEVICE, 5MM
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...
PRAIRIE CRUISER
FDA 510(k)
FDA Class 2
·Physical Medicine
ERCHONIA PL2000
FDA 510(k)
FDA Class 2
·Physical Medicine
AO LARGE REAMER ATTACHEMNT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code HWE·October 23, 2023
UNK ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·March 27, 2013
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 17, 2011
PRECISION XTRA / OPTIUM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 1, 2008
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 25, 2023
STOCKERT CORONARY PERFUSION CANNULAE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019
CUST 32MM FRDM LNR SZ22 +5MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 23, 2021
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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