14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oxyfit Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
VITA TITANKERAMIK
FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2038120·VITA TITANKERAMIK OPAQUE DENTINE, B3, 12 g
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114094·SIMCOE CORTEX EXTRACTOR 23GA 0.4MM PK/10
Disposable Iris Retract
FDA UDI
KATENA PRODUCTS, INC.·00841668114346·FLEXIBLE IRIS RETRACTORS 5 PKS of 5
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361021223·Arena-C HA, 11X17 Lordotic, 12mm
VACUETTE SPEEDY QUICK-RELEASE HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGX
FDA UDI
Widex A/S·05706069749854·Audigy AGXWU-IP (Clay brown S-440 ) Right
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 11, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 23, 2014
USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NKB·July 3, 2013
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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