16 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756977920·INTL-CATH LAB PACK
ZLB - PG&E Large Wound (Field Kit)
FDA UDI
Certified Safety Manufacturing, Inc.·00766588100227·ZLB - PG&E Large Wound (Field Kit)
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0100220·Caddie, Rods, Adjustable Cross Links, and Caps
Matira
FDA UDI
Kalitec Direct LLC·B07307K0100220·Assembly, Caddie, 1-3L Plates, Hnged
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100220·SNII Awl Tap, 6.50mm
SPINAL NEEDLE 27GA 3.50 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 8, 2021
SafeBreath Filter Mouthpiece
FDA 510(k)
FDA Class 2
·Anesthesiology
SRD III
FDA 510(k)
FDA Class 1
·Microbiology
SPINAL NEEDLE 27GA 3.50 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·October 1, 2020
AMS SPARC SLING SYSTEM
FDA Adverse Event
Death
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·June 11, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 10, 2010
BIOPATCH 4150
FDA Adverse Event
Injury
·INTEGRA NEUROSCIENCES PR·Product code FRO·December 18, 2012
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025