20 results
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25ms
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Sources: EU EUDAMED, US FDA
ENDOVASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Aligned Medical Solutions
FDA UDI
Aligned Medical Solutions·B09800213630·Ultrasound Percutaneous Core Kit
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854002643·ULTRAPOWER BUR, ROUND DIAMOND (LIME), 3 MM
NA
FDA UDI
STERILMED, INC.·10888551018548·BUR DIAMOND ROUND 140 GRIT
Build-up Cap for Ring & Tandem, 7.5mm (white)
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020154·
Build-up Cap for Ring & Tandem, 5.0mm (black)
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330020147·
SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 15, 2021
JOE LUBE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN
FDA Adverse Event
Malfunction
·Product code FOZ·August 12, 2021
AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024
BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·September 9, 2024
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007
11.0MM/8.0MM PROTECTION SLEEVE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·March 26, 2013
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 8, 2011
PROTEGE RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code NIM·July 11, 2023
SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
FDA Adverse Event
Malfunction
·Product code FOZ·August 19, 2021
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018