12 results
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32ms
·
Sources: EU EUDAMED, US FDA
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
FDA 510(k)
FDA Class 3
·Cardiovascular
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
36MM I.D. SIZE F HIGH WALL LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 5, 2024
BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 9, 2024
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
ON-Q PAINBUSTER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·June 13, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
UNK - PLATES: LCP
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·May 8, 2026
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015