15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PRESSURE MONITOR, MODEL 1131B
FDA 510(k)
FDA Class 2
·Cardiovascular
Alice
FDA UDI
Rmo, Inc.·00885797488862·ROTH ALICE 3-3 022 W/O HK 12 BKTS
RTI Allograft Paste
FDA UDI
Rti Surgical, Inc.·00854095006979·Allograft Paste 10cc
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038011101·NUPRO® Prophy Paste, Orange, Coarse, 340g Jar, ...
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117460·Jaffe Tying Forceps, Straight
NA
FDA UDI
Zimmer, Inc.·00889024376724·
VIDAS® FT4 ASSAY
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code CEC·July 19, 2017
PRESSURE MONITORING TUBING
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DRS·September 16, 1998
CRYSTAL-EEG MODEL 15
FDA 510(k)
FDA Class 2
·Neurology
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD PHASEAL¿ PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 11, 2018
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 8, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·October 17, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 11, 2007
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