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

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SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

DSP Implant System

FDA 510(k)
FDA Class 2 ·Dental

PALGARAPID

FDA 510(k)
FDA Class 2 ·Dental

CADD-LEGACY® PCA AMBULATORY INFUSION PUMP

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD INC.,·Product code MEA·March 29, 2016

NOTINGHM SHLDR HUM HEAD 48X17 OFFSET

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code KWS·January 19, 2016

OMNIPOD INSULIN PUMP

FDA Adverse Event
Injury ·INSULET CORPORATION·Product code LZG·February 28, 2013

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 4, 2011

CONCERTO II CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

FDA Enforcement
Class II ·Terminated·Cook Inc.·September 23, 2020