21 results
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20ms
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Sources: EU EUDAMED, US FDA
SANARUS VISICA TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005725·COSMETIC 20/40 LL CUSP 018 T=0 A+3 R=0
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113591·PS-C Insert, Size 3 x 14mm
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981157227·Cambria Trial without Depth Stop
3/8” collection set with x 8ft with handle & adapter
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Medgyn International, Inc·1 device
PYRENEES® Cervical Plate System
FDA UDI
VB Spine LLC·10888857241978·Translational Plate, Compressor
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR
FDA 510(k)
FDA Class 1
·General Hospital
DYONICS ELECTROBLADE RESECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 19, 2023
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 19, 2023
BD ALARIS SMARTSITE¿ NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 18, 2023
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 19, 2023
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 9, 2023
BD SMARTSITE¿ NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·October 11, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·March 17, 2011
LIGASURE LAPAROSCOPIC SLR/DIV
FDA Adverse Event
Malfunction
·COVIDIEN LP (US SURGICAL)·Product code GEI·March 31, 2008
HOMEPUMP C-SERIES: 270ML, 5ML/HR
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·November 7, 2014
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