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

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TSRH SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515061958·O.R. Sci, S/S, cvd, 5"

BONE REDUCTION CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051102·BONE REDUCTION CLAMP WITH EXTRA LONG RATCHET & ...

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172971185·

NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE

FDA 510(k)
FDA Class 2 ·Dental

VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER

FDA 510(k)
FDA Class 2 ·Ophthalmic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 3, 2026

QUANTUM MAVERICK BALLOON CATHETER

FDA Adverse Event
Injury ·Product code LOX·May 9, 2013

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 19, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE SET, ADMINISTRATION, FOR PERITON·Product code KDJ·May 25, 2011

GALAXY G3 MINI 2MM X 4CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

GALAXY G3 5MM X 15CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

GALAXY G3 MINI 3MM X 8CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

FDA Enforcement
Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 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

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

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