15 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.

Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2

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

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII

Oticon

FDA UDI
Oticon A/S·05707131287380·H11V2, MINIRITE 312 WL STG

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820052·Marina Dissector, 5mm Langenbeck Chisel Tip, Sl...

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 19, 2019

HEARTWAY POWER CHAIR, P23

FDA 510(k)
FDA Class 2 ·Physical Medicine

E-POLY (VITAMIN E) ACETABULAR LINERS

FDA 510(k)
FDA Class 2 ·Orthopedic

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 30, 2007

CLAMP, THORACIC, RADIOLUCENT

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 30, 2019

SENSOR ENLITE

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZO·October 7, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

TANGO INFINITY

FDA Adverse Event
Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·May 6, 2016

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024