13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARIES DETECTOR
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673198·LEVAMED STABILI-TRI ANK SUP BLU R III
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482050743·Symmetry® Knife Handle, #3, Standard, 12 in, 30...
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 14, 2026
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107065·KNIFE HANDLE, 12", #3, STND
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·September 6, 2023
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·March 12, 2008
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022