8 results · 17ms · 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.

RIM-HAEMOPHILUS 1 & 2

FDA 510(k)
FDA Class 1 ·Microbiology

VISULAS green

FDA 510(k)
FDA Class 2 ·Ophthalmic

BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P

FDA 510(k)
FDA Class 3 ·Cardiovascular

ARIS TRANS-OBTURATOR

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code FTL·February 7, 2014

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 14, 2012

ACRYSOF IQ TORIC

FDA Adverse Event
Malfunction ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·September 3, 2010

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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