20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRAGARD IMPERVIOUS REINFORCED GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK INFORM METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PERFORMANCE TOTAL KNEE PROSTHESIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019
MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE)
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code LFG·April 1, 2024
PERFORMANCE DISTAL FAB LM/RL MED
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
PERFORMANCE DISTAL FAB LL/RM MED
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
US CATHENA 22GX1.00IN STRAIGHT BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 4, 2021
US CATHENA 22GX1.00IN STRAIGHT BC
FDA Adverse Event
Malfunction
·Product code FOZ·May 7, 2021
VANGRD CR POR/HA FEM - RT 72.5
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 31, 2016
TINBN VNGRD INT CR ANAT FEMORAL R 62.5 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 31, 2016
VANGUARD CR POROUS/HA FEM - RT 72.5
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 23, 2016
GREENLIGHT HPS FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·March 26, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 14, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2008
VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 20, 2017
VANGUARD CRUCIATE RETAINING POROUS HA FEMUR - RIGHT 65 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·May 12, 2017
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018