15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Neuromuscular Transmission Monitor TOF3D (2510091)
FDA 510(k)
FDA Class 2
·Anesthesiology
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026
GONGDONG DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Para-Fix C&S Medium
FDA 510(k)
FDA Class 1
·Microbiology
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 28, 2025
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·December 2, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOM·September 16, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·July 29, 2013
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·April 22, 2020
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code MFD·February 28, 2020
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018