16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JAZZY 600
FDA 510(k)
FDA Class 2
·Physical Medicine
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040060183·Disposable Prophy Angle LF
Bard® LeFort Metal Sound
FDA UDI
C. R. Bard, Inc.·00801741032448·Bard LeFort Metal Sound, Threaded Tip, Stainles...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809866292·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776315764·Probe, with eye,
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403042612·26mm x 120mm Portal Tube
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981183110·15x13x12mm Rasp, Flat
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356399·
CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE
FDA 510(k)
FDA Class 2
·Cardiovascular
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013
LD CV EZTRK 2 BP IS1 4543 90CM US
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 6, 2011
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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