17 results
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42ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KERR GEL ETCHANT
FDA 510(k)
FDA Class 2
·Dental
Implant Prosthetics
FDA UDI
Preat Corporation·00842092127339·ASC NobelActive™/Conical-compatible RP Screw
PowerPICC Provena
FDA UDI
Bard Access Systems, Inc.·00801741200915·Catheter Placement Kit
ALGO 5
FDA UDI
Natus Medical Denmark ApS·05713315012181·PRINTER WITH DUALLOCK / PAPER
GentleYAG
FDA UDI
Candela Corporation·00817495020327·Pulsed Laser
MINIMED SILHOUETTE
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 9, 2025
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
FDA 510(k)
FDA Unclassified
·Unknown
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 2, 2026
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·September 15, 2024
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
HAKIM PROG VALVE INLINE SIPHONGUARD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·February 18, 2011
SILICONE ADVANCED OPTIC LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·February 20, 2008
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024