15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033044·Baltic Denture System BDLoad Sm7 PLSEbm6DFs D2 ...
Methamphetamine (300) Urine Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000382·Methamphetamine (300) Urine Cassette Test
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B073K0380440·Egg Handle, 1.75" Ratcheting, Quarter Square, C...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm
SYNTHES 3.9 MM PELVIC SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
COPELAND RESURFACING HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Zimmer, Inc.·00889024114258·
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 1, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 29, 2011
RSVR MMT-103A 10PK 3CC 13L STRL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FMF·April 22, 2008
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024