21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CB PROT II Posterior Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741426550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674142655060·
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052016203·Double Meniscus Cutter 5,5
Sonic
FDA UDI
Sonic Innovations, Inc.·05711584052259·BL100 NR, PS MAC BLISS 100
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776166809·GROOVED DIRECTOR TONGUE TIE WITH PROBE
Zavation
FDA UDI
Zavation LLC·00842166149946·14x26x55mm, 0°, MILC
Zavation
FDA UDI
Zavation LLC·00842166150690·14x26x55mm, 6°, MILC
Zavation
FDA UDI
Zavation LLC·00842166154230·14x26X55mm, 12°, MILC
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
FDA 510(k)
FDA Class 2
·Anesthesiology
BD INSYTE AUTOGUARD YEL 24GA X .75IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 29, 2024
T7 DRIVER CANN AO
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code LXH·July 14, 2016
PELVICOL ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·March 8, 2013
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 26, 2014
BREEZE2 TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·June 21, 2011
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015