12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
FDA 510(k)
FDA Class 2
·Radiology
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
FDA 510(k)
FDA Class 2
·Orthopedic
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026
DR FOG TREATED SPONGE, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·March 3, 2023
2520274-2013-03684
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 21, 2013
SLIDE TRIAL HANDLE
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·July 5, 2011
ADULT DUAL-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 25, 2008
MOBILETT ELARA MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code CBK·April 18, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013