12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Preset Syringe & BD A-Line Syringe
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113431·CRESCENT KNIFE DOUBLE BEVEL (BX/5)
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
FDA 510(k)
FDA Class 2
·Radiology
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES·Product code LJS·November 12, 2024
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DRC·March 11, 2026
ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO
FDA Adverse Event
Malfunction
·MEDTRONIC VASCULAR·Product code MIH·October 8, 2008
ENDO GIA ROTICULATOR 45-3.5 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·August 5, 2011
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·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