19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE MAESTRO SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150531·Endo Carry-on Procedure Kit Includes Basin, Int...
VIvid NuFil Syringe A-2
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0104580·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363260·Smith Ramus Separator
OneTouch Ultra
FDA UDI
LifeScan U.S. LLC·00353885458023·One Touch Ultra Control Solution
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036008086·
BRONCHO CATH ENDOBRONCHIAL TUBE, 37FR
FDA Adverse Event
Malfunction
·MALLINCKRODT MEDICAL·Product code CBI·June 15, 2001
SYNCHRON CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Logical G-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215094447·
CELSITE ACCESS PORT
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
THUNDERBEAT
FDA Adverse Event
Malfunction
·OLYMPUS AMERICA, INC.·Product code GEI·March 16, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 8, 2011
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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 Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024