21 results · 30ms · Sources: EU EUDAMED, US FDA

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COROENT INTERLOCK SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Epredia

FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693217880·Double Cytofunnel is a disposable sample chambe...

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

FDA 510(k)
FDA Class 2 ·Ophthalmic

UNIFY CRT-D

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

HS III PROXIMAL SEAL SYSTEM 3.8MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 27, 2014

TPS UNIVERSAL DRIVER

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·May 19, 2011

UNKNOWN HIP ACETABULAR CONSTRUCT DURALOC

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·August 23, 2024

UNK HIP ACETABULAR LINER POLY

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 23, 2024

UNK HIP ACETABULAR CUP DURALOC

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·August 23, 2024

UNKNOWN HIP FEMORAL CONSTRUCT CORAIL

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·July 1, 2025

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

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Model Number L231, PROPONENT DR EL MRI Pacemaker

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

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

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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