101 results · 23ms · Sources: EU EUDAMED, US FDA

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MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

Medtronic Reusable Instruments

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902097140·CYLN ENDO 18MM INNER TRAY

Disc Prep

FDA UDI
Life Spine, Inc.·00190837089917·

Wayne

FDA UDI
COOK INCORPORATED·00827002565364·Wayne Pneumothorax Set

CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PASS LP SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

WAYNE PNEUMOTHORAX SET

FDA Adverse Event
Injury ·COOK INC·Product code JOL·July 22, 2020

CHARGER?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025

CHARGER?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 21, 2025

CHARGER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·June 2, 2025

S-ROM M HEAD 36MM +0

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·August 28, 2013

PINNACLE MTL INS NEUT36IDX56OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 28, 2013

COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

CHARGER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 27, 2025

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code JOL·October 17, 2024

Wayne

FDA UDI
COOK INCORPORATED·00827002111820·Wayne Pneumothorax Set

CHARGER?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 10, 2025

CHARGER?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025

CHARGER?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 6, 2025

CHARGER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 25, 2025