11 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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InRoad® Dental Synthetic Bone Graft
FDA 510(k)
FDA Class 2
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112601·BARRON CORNEAL PUNCH 7.25MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694049542·4.0mm Cannulated Depth Gauge / Countersink
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)
MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
FDA 510(k)
FDA Class 2
·Dental
PROXIMATE** LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 8, 2011
ETS FLEX ARTICNG LNR CUTR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 2, 2013
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
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