21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MALE NATURAL RUBBER LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964152825·Endo Carry-on Procedure Kit contains Basin, VIA...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890109190·Zirlux 30 Degree Multi-Unit Abutment 3 mmH comp...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756233422·BONE MARROW TRAY
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033248614·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033248638·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033344125·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00191905788800·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033248645·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm
WAKO AUTOKIT LP(A)/DADE DEMENSION
FDA 510(k)
FDA Class 2
·Immunology
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
FDA 510(k)
FDA Class 2
·Neurology
BD CONNECTA STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·February 6, 2020
VUE PACS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025
LOGIC FEMORAL PS CEM LEFT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 3, 2025
XIA BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code KWP·March 19, 2013
ENDURANT BIFURCATED STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·March 4, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
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
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019