19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MOSS MIAMI 5.5MM TITANIUM PIN NUT
FDA 510(k)
FDA Class 2
·Orthopedic
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151934·Endo Carry-on Procedure Kit contains Basin, VIA...
Aligned Medical Solutions
FDA UDI
Aligned Medical Solutions·B09800107420·Port Tray
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033208830·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100420·Assembly, Caddie, Adjustable Cross Links
JAW INS. BULLET NOSE GRASPER 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015
RESUSCI INFLATE-A-SHIELD CPR BARRIER
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNTHES ANTERIOR CSLP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 30, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
R3
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 19, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 2, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·August 22, 2018
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 12, 2019
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·October 1, 2014
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