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