26 results · 22ms · 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.

QUANTUM SPINAL SYSTEM, QUANTUM MIS

FDA 510(k)
FDA Class 2 ·Orthopedic

Aequalis™ Adjustable Reversed

FDA UDI
TORNIER, INC.·00846832068166·

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540134202·SPATULA, MALLEAB., DOUBLE-ENDED

Sklar

FDA UDI
SKLAR CORPORATION·10649111382000·STERLIZATION POUCH RACK 4 X 18

Molar Rotation2 Appliance

FDA UDI
Ortho Organizers, Inc.·00190707064525·NITANIUM® MOLAR ROTATOR2 APPLIANCE (44mm)

MICROCRUISER PLUS INTRODUCER SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

COULTER LIN-X LINEARITY CONTROL, MODEL A81196

FDA 510(k)
FDA Class 2 ·Hematology

SMR SHOULDER SYSTEM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code PHX·May 18, 2026

HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code KWZ·September 26, 2016

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011

DYN-LOCK-SCR Ø5 SELF-TAP L40 COCRMO

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HWC·May 9, 2013

SMART CONTROL NITINOL STENT SYSTEM

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code FGE·August 5, 2008

ACCESS ACCUTNI REAGENT

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 2024

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Model Number L101, ESSENTIO DR SL Pacemaker

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

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

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021