17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Storz Medical MAGNETOLITH Muscle Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113592·PERIBULBAR NEEDLE 25GA 16MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113851·ARBISSER ANTERIOR CHAMBER CANNULA 30GA ANG 7MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114018·HYDRO-DISSECT FLAT J 25GA (PK/10)
Arena-C
FDA UDI
SPINEFRONTIER, INC.·00190361023159·Arena-C HA, 11X17 Straight, 10mm
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISORB SWIFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TIBIAL NAIL, STANDARD T2 TIBIA 10X315 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 22, 2012
ANN PH NAIL RT 9X160MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·September 29, 2025
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
FDA Adverse Event
Injury
·VALERITAS, INC.·Product code LZG·October 23, 2014
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·June 25, 2013
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
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