19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
FDA 510(k)
FDA Class 2
·Orthopedic
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTRAINTS
FDA Adverse Event
Malfunction
·DEROYAL·Product code FMQ·January 15, 2014
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 15, 2015
ST. JOSEPH HSP BALTIMORE MD1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010
ASR ACETABULAR IMPLANT 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 3, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 16, 2014
INSORB SUBCUTICULAR STAPLER
FDA Adverse Event
Other
·INCISIVE SURGICAL·Product code GDW·May 5, 2011
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
SMART, PERFUSION PACKS, CONNECTORS, TUBING
FDA Adverse Event
Malfunction
·LIVANOVA USA·Product code DWE·August 1, 2023
CSC14 CARDIOLOGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·March 10, 2016
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·November 20, 2015
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
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