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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR

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

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193022752·B-P HIP ACETABULAR BEARING - 28 MM I.D. X 56 MM...

STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G

FDA 510(k)
FDA Class 1 ·General Hospital

AT3C70 TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008

CONTOUR THREAD

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 15, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Injury ·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 27, 2013

SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·March 17, 2011

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·March 28, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009

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

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018