14 results
·
24ms
·
Sources: EU EUDAMED, US FDA
QCA (VERSION 3.1)
FDA 510(k)
FDA Class 2
·Hematology
NEEDLE 18X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·June 7, 2024
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·June 5, 2024
IRRIGATION CATHETER, 4F, 80CM
FDA Adverse Event
Other
·APPLIED MEDICAL RESOURCES·Product code GBX·March 24, 2008
CROSSPOINT TRANSACCESS CATHETER
FDA 510(k)
FDA Class 2
·Radiology
JOE LUBE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSX·February 3, 2017
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 2, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 24, 2011
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·April 18, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024