21 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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PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bur PM2-70 80K Matchstick Ø3.0mm sterile
FDA UDI
Bien-Air Surgery SA·J00711004610011·
Bur PM2-70 80K Mstick Ø3.0 St
FDA UDI
Bien-Air Surgery SA·17630055504163·
GLOVER DEBAKEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004610·GLOVER DEBAKEY BULLDOG CLAMP CURVED
MALLET
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047594·MALLET WITH HARDENED REMOVABLE STAINLESS STEEL/...
GLOVER DEBAKEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002333·GLOVER DEBAKEY BULLDOG CLAMP CURVED
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167100461000·
ADVIA RETIC PLUS
FDA 510(k)
FDA Class 2
·Hematology
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PORTEX MINI-TRACH II SELDINGER KIT
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 10, 2019
MINI-TRACH® II SELDINGER TRACHEOSTOMY KIT
FDA Adverse Event
Malfunction
·Product code BTO·August 18, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013
U-BLADE INSERTER GAMMA3®
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·September 19, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·May 17, 2011
ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code PNY·June 22, 2020
ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code PNY·November 9, 2020
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 6, 2013
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code PPD·June 11, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020