13 results · 19ms · Sources: EU EUDAMED, US FDA

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VARELISA SM ANTIBODIES, MODEL 18296

FDA 510(k)
FDA Class 2 ·Immunology

DisposEvac All-in-One Surgical Aspirators

FDA UDI
PRACTICON, INC.·00723896010129·Replace your heavy, bulky metal HVE valves with...

SILMAX CONTOUR CARVING BLOCK IMPLANT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ALWAYS DUETS

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 20, 2024

LOGIC CR TIB INSERT STD, SZ 6, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 18, 2023

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 4, 2013

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 6, 2011

CONTAK RENEWAL 3

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

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