19 results · 21ms · Sources: EU EUDAMED, 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