14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGILL CATHETER INTRO. FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Precept
FDA UDI
Nuvasive, Inc.·00887517351654·PRECEPT Blade, Fascial
Codman
FDA UDI
SYNERGETICS USA, INC.·20886704065477·Disposable Spetzler™-Malis® Standard Bipolar Fo...
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRACAPS S
FDA 510(k)
FDA Class 2
·Dental
CODMAN STD FORCEPS 20CMX1.0MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GEI·May 8, 2017
CURRENT RF DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 23, 2012
ASR ACET IMP 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·August 11, 2010
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·March 6, 2013
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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