27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base
HC-BIOS DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
SureFISH PML RARA DF
FDA UDI
AGILENT TECHNOLOGIES, INC.·05700574033347·SureFISH PML RARA DF
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756814232·RIGID COLLAR
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158218239·FORCEPS USA DRESSING STRAIGHT 10"
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HASKAL TORQUE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·September 19, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 10, 2024
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
LIT SUR PIEDS ROUL SUP CHASSIS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 25, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 8, 2020
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013