12 results · 18ms · 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.

STERILE SURGICAL LATEX GLOVES

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

EasyTouch

FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18827151·

Arthrex®

FDA UDI
ARTHREX, INC.·00888867386532·Cortical Screw, 2.7 mm x 15 mm

Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

DEPUY GLOBAL AP CTA HUMERAL HEAD

FDA 510(k)
FDA Class 2 ·Orthopedic

GEMSTR 7 THPY ALT ST

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 10, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·October 21, 2010

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code BTI·December 20, 2012

Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions

FDA Recall
Open, Classified ·Gentell, Inc·Product code FRO·March 26, 2020

Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

FDA Recall
Open, Classified ·Gentell, Inc·Product code FRO·March 26, 2020

Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

FDA Recall
Open, Classified ·Gentell, Inc·Product code FRO·March 26, 2020

Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

FDA Recall
Open, Classified ·Gentell, Inc·Product code FRO·March 26, 2020