16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STERILE TONSIL SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLI Twin
FDA UDI
Rmo, Inc.·00885797489517·FLI(R) TWIN MBT .018/022 HK345 5-5 20 BKTS
Bardia® Piston Irrigation Tray
FDA UDI
C. R. Bard, Inc.·00801741052217·Bardia® Piston Irrigation Tray
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM
SuperCable® ISO-Elastic™ Cerclage System
FDA UDI
Kinamed, Inc.·00818720013305·TalonPasser™, Medium, 60mm
CRANIAL IMAGE GUIDED SURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·October 23, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 2010
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·July 30, 2024
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·March 6, 2024
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024