16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
FDA 510(k)
FDA Class 2
·Anesthesiology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551202128·MICCOLI Tissue Retractor
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137107·
ACUMED
FDA UDI
Acumed LLC·10806378052354·ARH Head Removal Tool Long Stem Adaptor
THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
FDA 510(k)
FDA Class 2
·General Hospital
IM-9B MICROINJECTORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
XLPE LINER STANDARD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·April 29, 2019
XLPE LINER STANDARD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 19, 2018
KINECTIV MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 19, 2018
M / L TAPER G2 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 19, 2018
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 28, 2015
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
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 REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024