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

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WATERLASE MD TURBO PLUS MODEL 7200XXX

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

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664009328·BELLA STRONG 15-20 MM HG GAUNTLET SIZE 6 BLACK ...

Sklar

FDA UDI
SKLAR CORPORATION·30649111363607·BRUSH STAIN STEEL BRISTL PK/24

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450205686·

U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HAMILTON-C6

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 30, 2013

ON-Q PAINBUSTER: SOAKER 2.5IN: 100ML, 2ML/HR

FDA Adverse Event
Injury ·I-FLOW, LLC·Product code MEB·August 28, 2014

STENOSCOP

FDA Adverse Event
Malfunction ·GE MED SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·May 11, 2011

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 24, 2020

DC BEAD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRD·July 29, 2022

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

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

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

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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