19 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310217013·FG Diamond 863-016 flame coarse 5/pack
PureBliss
FDA UDI
PURELIFE, LLC·D79010217011·PureBliss Latex Powder-Free, X-Small, PureLife ...
Vital Signs™
FDA UDI
AirLife Finland Oy·10190752179301·Direct Connect Temperature Cable for GE Monitor...
Vital Signs
FDA UDI
Carefusion Finland 320 Oy·10885403256042·Direct Connect Temperature Cable for GE Monitor...
Vital Signs™
FDA UDI
AirLife Finland Oy·10889483576304·Vital Signs™ direct connect temperature cable f...
Vital Signs™
FDA UDI
AirLife Finland Oy·10190752113657·Direct Connect Temperature Cable for GE Monitor...
VIDAS® Varicella-Zoster IgG
FDA UDI
BIOMERIEUX SA·03573026644796·VIDAS VARICEL. ZOSTER IGG assay is a qualitativ...
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
FDA 510(k)
FDA Class 2
·Hematology
Phonak
FDA UDI
Sonova AG·07613275553091·Phonak Virto B70-10
Phonak
FDA UDI
Phonak AG·07613275257906·Phonak Audéo V50-13 (beige)
ONESTEP CPR AA
FDA Adverse Event
Malfunction
·BIO-DETEK INCORPORATED·Product code MKJ·November 26, 2025
ULTRASONIC IMAGING CATHETER - CORONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·March 26, 2013
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 17, 2011
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·February 19, 2020
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
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