14 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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TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813841·GENUMEDI PRO SILVER SIZE IV
ArgenZ Anterior 95x14 #4
FDA UDI
ARGEN CORPORATION, THE·D818121264·Dental porcelain/ceramic restoration kit
CORNEAL TREPHINE BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896099821·CORNEAL TREPHINE BLADE
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383505857·Gutta Percha Points is used to root canal filin...
TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT
FDA 510(k)
FDA Class 2
·Physical Medicine
TEMPUS IC PROFESSIONAL PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 20, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
XCEL DILATING TIP TROCAR 11MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·August 18, 2008
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GWO·April 16, 2018
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024