13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diapex Plus
FDA 510(k)
FDA Class 2
·Dental
Bioseal Inc.
FDA UDI
BIOSEAL·00630094018263·Drape Fenestrated Polylined STERILE
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122292·Kwire .070X9" (1.8x225mm)
VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
CADD LEGACY 1 PUMPS 6400
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·February 3, 2023
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·March 6, 2019
PLATE,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·May 9, 2014
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·July 5, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 21, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code MHY·July 23, 2008
Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450
FDA Recall
Terminated
·Steris Corporation·Product code GDC·February 6, 2007
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021