19 results · 32ms · Sources: EU EUDAMED, US FDA

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Multiflex Steerable Sheath

FDA 510(k)
FDA Class 2 ·Cardiovascular

CoRoent

FDA UDI
Nuvasive, Inc.·00887517288196·CoRoent® XL-CTW, 16x22x55mm, 10°

CoRoent

FDA UDI
Nuvasive, Inc.·00887517300560·CoRoent® XLK, 16x18x55mm 10°

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074362342·SCREW 7221655 HA COATED CANN 6.5 X 55

BD BBL™ Indole Nitrite Medium

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902216552·BD BBL™ Indole Nitrite Medium

ARKEO, Wedge Fixation System

FDA UDI
Auxano Medical LLC·00850055649842·ARKEO Cotton Wedge, 16x11x5.5

Vu aPod™ - L

FDA UDI
Seaspine Orthopedics Corporation·10889981046606·LATERAL TRIAL, WIDE, STANDARD, 16mm X 23mm X 55mm

BD ALCOHOL SWAB

FDA 510(k)
FDA Unclassified ·Unknown

aPROMISE

FDA 510(k)
FDA Class 2 ·Radiology

BD SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019

CAPTURE-R READY-SCREEN (3)

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·August 10, 2016

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 24, 2011

CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 3, 2014

SINGLE ULTRASONIC DISSECTOR

FDA Adverse Event
Malfunction ·COVIDIEN LP·Product code LFL·July 1, 2013

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 14, 2020

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025