11 results · 20ms · Sources: EU EUDAMED, US FDA

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FLEXIMA BILIARY CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Safco Kleer Mirrors

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310238703·Safco Kleer mirror simple stem #5 12p

PERSONAL BEST

FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000466·PERSONAL BEST LR PFM-RUSSIA-SINGLE UNIT

SAFETYGLIDE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·May 20, 2025

SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

THROMBOREL S

FDA 510(k)
FDA Class 2 ·Hematology

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·March 27, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·February 14, 2011

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008

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