13 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Healqu
FDA UDI
Healqu LLC·00819143020970·Healqu Hydrogel Sheet Dressing 4in x 4in
24PW - Hanta Virus
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450157145·
ADVIA IMS
FDA 510(k)
FDA Class 1
·Clinical Toxicology
INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
FDA 510(k)
FDA Class 2
·Anesthesiology
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 12, 2024
UNKNOWN DEPUY STD+ PATELLA
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 26, 2013
PENUMBRA SYSTEM ASPIRATION PUMP
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code BTA·February 8, 2011
SYNERGY COMPACT
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 19, 2014
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016