14 results
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28ms
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Sources: EU EUDAMED, US FDA
LDC CHROMATOGRAPHY ACCESSORY MODULE B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000460·Dual Surgical Vac Pump Package | NFPA Cat 2 | 5...
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D9098000461·MOLAR DIRECT BOND BRACKET POSITIONER
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100361·KIT, CCR-MEDIC LEG RIG - BLK; This kit contains...
ACUMED
FDA UDI
Acumed LLC·10806378039522·Wrist Fusion Trial Tray Insert
Pilot Spinal System
FDA UDI
Life Spine, Inc.·00190837008918·
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
FDA 510(k)
FDA Class 2
·Cardiovascular
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 8, 2014
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·October 17, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 12, 2010
BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FMI·October 5, 2010
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
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