19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROOT ZX II
FDA 510(k)
FDA Class 1
·Dental
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197175135·Antrum Curette oval Fig. 1
7mm, 2...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867462052·Dilator, 7.1 x 190mm
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
FDA 510(k)
FDA Class 1
·General Hospital
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 16, 2022
DILATOR, 4.1 X 220MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·October 29, 2024
DILATOR, 6.0 X 200MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·December 2, 2024
DILATOR, 6.0 X 200MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·October 29, 2024
DILATOR, 7.1 X 190MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·October 29, 2024
DILATOR, 7.1 X 190MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·November 26, 2024
DILATOR, 5.1 X 210MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·December 2, 2024
DILATOR, 5.1 X 210MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·October 29, 2024
DILATOR, 4.1 X 220MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HNW·December 2, 2024
Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
DORADO PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·April 8, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 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