27 results · 21ms · Sources: EU EUDAMED, 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