22 results · 28ms · Sources: EU EUDAMED, US FDA

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RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NexPak X

FDA UDI
HEMOSTASIS, LLC·00858439001637·NexPak X Intranasal Splint is a sterile flexibl...

5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

FDA Adverse Event
Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 26, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·March 2, 2015

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK

IMPLANT, FIXATION DEVICE CONDYLAR PLATE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CROSS-CHECKS DUAL, MODEL CI 125

FDA 510(k)
FDA Class 2 ·General Hospital

IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

TRIXIE

FDA Adverse Event
ARJO MED AB LTD·Product code FSA·April 8, 2013

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZO·September 23, 2014

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 1, 2011

STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

FDA Adverse Event
Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790

FDA Recall
Terminated ·Whatman, Inc.·Product code JKA·October 29, 2009

Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·August 30, 2017

Video Duodenoscope

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·June 8, 2016