17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
FDA 510(k)
FDA Class 2
·Anesthesiology
ConMed/Linvatec
FDA UDI
Provision·B504OM50231400·
CONMED
FDA UDI
Conmed Corporation·10845854005774·MICRO SAGITTAL BLADE, FINE, 9.5 X 41 X 0.4 MM
NA
FDA UDI
STERILMED, INC.·10888551019446·SAW BLADE SAGITTAL TAPERED/FINE TOOTH
SurgiTouch Scanner
FDA UDI
LUMENIS LTD.·07290109146720·
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
VOXAR'S CALCIUM SCORING PRODUCT
FDA 510(k)
FDA Class 2
·Radiology
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·April 11, 2023
ALARIS PUMP MODULE IV ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·February 27, 2013
TRELLIS 6 80X10
FDA Adverse Event
Malfunction
·COVIDIEN·Product code KRA·February 15, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
1.5 4 HOLE REG STRAIGHT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·December 12, 2017
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·August 11, 2021
2.0/1.0 2/2 HOLE LEFT LONG L
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·December 12, 2017
2.0/1.0 4 HOLE MED
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·December 12, 2017
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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014