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

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FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

FDA 510(k)
FDA Class 2 ·General Hospital

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120222601·Carbide, cone pointed, ultra-fine finishing bur...

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981173685·Closed, Axial Rod, Long, 260mm

WIENER LAB. UREA UV CINETICA AA

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SPINA SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 27, 2025

PERCUTANEOUS CANN CONNECTING SCREW F/TROCH FIXATION NAILS

FDA Adverse Event
Injury ·SYNTHES USA·Product code LXH·March 26, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011

COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

FDA Adverse Event
Malfunction ·STAAR SURGICAL CO.·Product code HQL·March 26, 2008

UNK_INTRALASE_FEMTOSECOND LASER

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC·Product code HNO·March 17, 2023

STOCKERT CORONARY PERFUSION CANNULAE

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·November 16, 2022

NYLON SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAR·November 16, 2022

UNKNOWN VICRYL RAPIDE SUTURE

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·November 16, 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

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