21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854005378·ULTRAPOWER BUR, OVAL (MUSTARD) 4 MM X 8 MM
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 9, 2021
Reicodent
FDA UDI
devemed GmbH·04061644050499·Excavator # 127/128 | 1.7 mm
double ended
Octag...
Reicodent
FDA UDI
devemed GmbH·04061644050505·Excavator # 129/130 | 1.5 mm
double ended
Octag...
Reicodent
FDA UDI
devemed GmbH·04061644050529·Excavator # 133/134 | 1.0 mm
double ended
Octag...
Reicodent
FDA UDI
devemed GmbH·04061644050482·Excavator # 125/126 | 2.1 mm
double ended
Octag...
Reicodent
FDA UDI
devemed GmbH·04061644050512·Excavator # 131/132 | 1.2 mm
double ended
Octag...
RESTORE-PF VIC; RESTORE-PF VLC CAPSULE
FDA 510(k)
FDA Class 2
·Dental
PIPER
FDA 510(k)
FDA Class 2
·Radiology
Reicodent
FDA UDI
devemed GmbH·04061644035014·Excavator # 127/128 | 1.7 mm
COMFORT | SL | dou...
Reicodent
FDA UDI
devemed GmbH·04061644034987·Excavator # 133/134 | 1.0 mm
COMFORT | SL | dou...
Reicodent
FDA UDI
devemed GmbH·04061644035007·Excavator # 129/130 | 1.5 mm
COMFORT | SL | dou...
Reicodent
FDA UDI
devemed GmbH·04061644035021·Excavator # 125/126 | 2.1 mm
COMFORT | SL | dou...
Reicodent
FDA UDI
devemed GmbH·04061644034994·Excavator # 131/132 | 1.2 mm
COMFORT | SL | dou...
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 26, 2013
DERMABOND PROPEN
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MPN·March 7, 2011
SCREW CORTICAL 3.5 X 16MM
FDA Adverse Event
Injury
·DEPUY ACE S.A. R.L.·Product code HWC·March 28, 2008
Allura Xper FD20; Model Number: 722006;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 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