22 results · 26ms · Sources: EU EUDAMED, US FDA

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CORTOSS BONE AUGMENTATION MATERIAL

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014604558·MULTI-AXIS PAD 16" X 6" X 2" CONCAVE DELUX

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306815188·DeBakey Needle Holder, Serrated Jaws, 20cm

Symmetry Malis®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140024·Symmetry® Bipolar Forceps; Bayonet; Straight; T...

Track A

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR4080108·Track A ø 0,8 x 125 mm

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450179482·

Maxtown Medical

FDA UDI
Modern Surgical Instruments LLC·B419350801080·BP IN K-YASAR 1.3T BAY 7.88

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm

CUSTOME KIT, CT-SET

FDA Adverse Event
Malfunction ·MERIT MEDICAL IRELAND, LTD.·Product code FPA·September 11, 2006

USS-LINE EXTENSION

FDA 510(k)
FDA Class 2 ·Orthopedic

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 4, 2025

VISION HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

NEXGEN LPS FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code NJL·April 24, 2013

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011

DPS PRESSURE MONITORING KIT W/ ANTI SHUNT

FDA Adverse Event
Malfunction ·SMITHS MEDICAL·Product code DRS·July 17, 2008

InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

FDA Enforcement
Class II ·Terminated·Philips Healthcare·February 5, 2014

HIP END EFFECTOR, VARIABLE ANGLE

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 22, 2019

InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

FDA Recall
Terminated ·Philips Healthcare·Product code NCX·January 13, 2014