13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MIS Ti-base Abutment
FDA 510(k)
FDA Class 2
·Dental
sentida 04
FDA UDI
WISSNER-BOSSERHOFF GmbH·04050621100432·Basic electric home bed
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191152811·IN-OVATION® mini EURO 022/UR5 -7T 0A HK
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013
ACCURUS 800CS
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 29, 2011
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 26, 2008
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
FDA Enforcement
Class II
·Ongoing·WISSNER-BOSSERHOFF GMBH·November 20, 2024
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025