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

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MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR

FDA 510(k)
FDA Class 2 ·Microbiology

COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS

FDA 510(k)
FDA Class 2 ·Orthopedic

PLATE BD CHROMAGAR O-157 20 EA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

PLATE BD CHROMAGAR O-157 20 EA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

CUSA EXCEL 23KHZ CEM NOSECONE

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES IRELAND LIMITED·Product code LFL·March 18, 2013

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 19, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 7, 2011

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

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

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024