21 results
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28ms
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Sources: EU EUDAMED, US FDA
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040015131·Zirlux 16+ D4 65x25x22
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112080·Tap, 7.50mm
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0112080·Rasp, 8 and 10mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112300·Tap, 8.5mm Cortical, SNI1
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112080·Tap, Cannulated, 6.5 mm
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
FDA 510(k)
FDA Class 2
·General Hospital
SCR REPLACEMENT SW-V GOLD COPING
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 19, 2017
SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 8, 2020
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code FZP·October 11, 2016
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code FTR·April 11, 2025
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·April 11, 2025
ULTRA-THIN¿ DIAMOND¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·March 19, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 8, 2011
*
FDA Adverse Event
HOSPIRA GLOBAL MEDICAL AFFAIRS·Product code FPA·February 25, 2008
CFF03, 5X100 KII FIOS ADVFIX 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·September 29, 2015
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011
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