12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PET-DOSE
FDA 510(k)
FDA Class 2
·Radiology
HairCheck-DT (PCP)
FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868302·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
ICE BATON
FDA 510(k)
FDA Unclassified
·Unknown
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
FDA 510(k)
FDA Class 1
·General Hospital
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·April 9, 2013
SYNCHRON UNICEL DXC 600PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JLB·April 6, 2011
ENDOTAK ENDURANCE RX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
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
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024