17 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....
NA
FDA UDI
aap Implantate AG·04042409037955·Drill guide insert CS 4.5, long
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024114·B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 75 MM
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973106500·TRIAL 90-SRK-160316 POLY CR 3X16MM
INFOSEND GSM
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
FDA 510(k)
FDA Class 2
·General Hospital
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·July 17, 2018
PINN CAN BONE SCREW 6.5MMX35MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·July 18, 2018
SROM*STM ST,36+8L NK,22X17X165
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code JDI·July 17, 2018
S-ROM*SLEEVE PRX ZTT, 22B-LRG
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·July 18, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2013
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
WECK HEMOCLIPS
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·April 28, 2011
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·April 3, 2025
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·November 16, 2017
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 28, 2016