17 results · 21ms · Sources: EU EUDAMED, US FDA

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PEFAKIT APC-R FACTOR V LEIDEN

FDA 510(k)
FDA Class 2 ·Hematology

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.·04042809869743·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

FDA 510(k)
FDA Class 2 ·Cardiovascular

MJS POSTERIOR STABILIZED KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON LEGACY MINI SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013

VITALITY AVT

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

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 6, 2011

ASAHI PROWATER

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

ASAHI PROWATER

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·March 10, 2016

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·March 10, 2016

Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·April 29, 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