11 results
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18ms
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Sources: EU EUDAMED, US FDA
SKIN STAPLER HANDLE 523700/CARTRIDGES
FDA 510(k)
FDA Class 2
·General Hospital
KATENA
FDA UDI
KATENA PRODUCTS, INC.·00841668123942·Flat Vitrectomy Lens w fixed ring
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209124725·KIT, K9 TACTICAL FIELD - w' CG ADV - BLK
SMILIE PC
FDA 510(k)
FDA Class 1
·Dental
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
UNKNOWN PRODUCT - GMRS PROXIMAL FEMORAL
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code KWY·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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