312 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

VisCalor

FDA 510(k)
FDA Class 2 ·Dental

AGXO

FDA UDI
Oticon A/S·05707131352231·G500 S, MINIRITE 312 2.4G C091 AGXO

OptoMonitor 3

FDA UDI
Opsens Inc·07540184013074·

Ophthlamic Speculum

FDA UDI
KATENA PRODUCTS, INC.·10841668115159·BARRAQUER SPECULUM Disposable with Finger tabs ...

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113820·VISCO CANNULA 25GA ANGLE 8MM

CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ

FDA 510(k)
FDA Class 2 ·Orthopedic

BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

3.5FR P.U.R. UMBIL CATH X10

FDA Adverse Event
Malfunction ·COVIDIEN·Product code FOS·July 12, 2013

ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

FDA Adverse Event
Injury ·ETHICON INC.·Product code KOG·April 7, 2014

MOUNTAINEER HEAD TO HEAD CROSS CONNECTOR INNER SCREW

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code KWP·March 13, 2014

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·August 30, 2013

epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

FDA Enforcement
Class II ·Terminated·Epocal·August 21, 2013

MEDIUM SPECIMEN RETRIEVAL BAG, 100MMX150

FDA Adverse Event
Malfunction ·GENICON·Product code FMH·April 21, 2015

HEARTSTREAM FR2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 3, 2011

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·September 17, 2014

HEART LUNG MACHINE

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·October 9, 2020

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 28, 2023

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 12, 2013

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013