20 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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Potenza
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446834069·SPECIAL, LINK ADJUSTING ARM
HHM
FDA UDI
Oticon A/S·05707131357373·G300 SC, MINIRITE R LI-ION 2.4G C090 HHM
NA
FDA UDI
Synthes GmbH·10886982142511·2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 15MM
CODMAN
FDA UDI
Cerenovus, Inc.·10886704066781·CODMAN SLIM-LINE Aneurysm Clip Straight Blade L...
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512794·"An absorbent paper points is an endodontic pap...
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
FDA 510(k)
FDA Class 2
·Anesthesiology
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·March 28, 2017
HAMILTON-C6
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025
SECUR-FIT MAX 132 HIP STEM #7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·August 22, 2016
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·June 28, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014
ARCHITECT CA 19-9XR
FDA Adverse Event
Injury
·ABBOTT LABORATORIES·Product code NIG·June 2, 2016
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 23, 2012
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 9, 2019
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 MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021