15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KHEIRON® Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446820710·Special, AltiVate Anatomic Modular Reamer Handl...
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023165·DMTL SmartFlex 400 High Energy Reusable (5X)
CODMAN
FDA UDI
Cerenovus, Inc.·10886704066750·CODMAN SLIM-LINE Aneurysm Clip Bayonet Blade Le...
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
FDA 510(k)
FDA Class 2
·Cardiovascular
MARATHON MICRO CATHETER AND ONYX
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code KRA·December 8, 2009
STERIS LARIAT
FDA Adverse Event
Malfunction
·STERIS / ISOMEDIX OPERATIONS INC.·Product code FDI·August 2, 2022
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 27, 2014
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWA·June 28, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
PROXIMAL HUMERUS, RIGHT, LONG, ÿ 7X260MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·April 22, 2025
BLUNT TIP SCREW, ÿ 4X46MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·March 7, 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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025