14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120210651·Carbide, cylinder round, excavating and fissure...
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005589·COSMETIC 20/40 SINGLE WIDTH LOWER ANT 022 T=0 A...
AOS ANTI-ROTATION SCREW 5.0mm x 65mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665019858·
Reicodent
FDA UDI
devemed GmbH·04061644045730·Towel clip "Backhaus" | 110 mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967162256·ANGLED THORACIC SUPRALAMINAR HOOK, RIGHT, 6.5mm
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTEX SPINAL ANESTHESIA TRAYS
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code CAZ·March 15, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011
ICL IMPLANTABLE COLLAMER LENS
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·March 27, 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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014