16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDICAL Z, S.A.
FDA registration
MEDICAL Z, S.A.·6 products·🇫🇷 France
SCAPHIX, STAPLE, FIXATION, BONE
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: HL168W TOUCH SCREEN
FDA 510(k)
FDA Class 2
·Cardiovascular
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 8, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 27, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
VUELOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
ARROW ARTERIAL CATH SET: 20GA X 8CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·October 11, 2019
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024