17 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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EVOS Large Fragment Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517628633·CoRoent Ant TLIF Ti, 10x13x40mm 15°
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184476·Accufit Molar Bands Lower Right Second Molar 40...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036814·Trial Rasp, No Stop, Assembly, Lordotic, 5mm
STILLE Uterine Curettes
FDA UDI
Stille AB·07332339205935·UTERINE CURETTE RECAMIER STILLE malleable sharp...
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN MINT TINGLE BRAND LATEX CONDOMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LS CLAVE PORT EXT 7"
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·October 15, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·July 2, 2013
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
FDA Enforcement
Class II
·Ongoing·Copan Diagnostics Inc·September 27, 2023
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025