211 results · 34ms · 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.

KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT

FDA 510(k)
FDA Class 2 ·Immunology

MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR

FDA 510(k)
FDA Class 2 ·General Hospital

STRAUMANN MEMBRAGEL

FDA 510(k)
FDA Class 2 ·Dental

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·November 22, 2019

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 6, 2019

EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code EOQ·June 2, 2011

TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code HXC·August 11, 2008

JOSTENT GRAFTMASTER

FDA Adverse Event
Death ·ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND·Product code MAF·August 3, 2006

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·June 27, 2019

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·October 17, 2019

CLAVE CONNECTOR

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·December 14, 2012

CLAVE CONNECTOR

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·December 14, 2012

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

HISTOACRYL BLUE TISSUE ADHESIVE

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·January 23, 2020

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·September 23, 2019

Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·March 8, 2019

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·August 6, 2019

HISTOACRYL BLUE 0.5ML

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·September 3, 2019

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty

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