26 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TSRH(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Endeavour™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00615375013540·Endeavour™ TruColor™ headlight system - North A...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111379598·MAYO INSTR HOLDER
Torcon NB
FDA UDI
COOK INCORPORATED·00827002060876·Torcon NB, Advantage Catheter
Torcon NB
FDA UDI
COOK INCORPORATED·00827002470309·Torcon NB Advantage Catheter
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
FDA 510(k)
FDA Class 2
·Ophthalmic
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
FDA 510(k)
FDA Class 2
·Anesthesiology
ACTIVA PC
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·October 18, 2010
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
DYN-LOCK-SCR Ø5 SELF-TAP L32 COCRMO
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·May 9, 2013
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·May 10, 2011
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 7, 2008
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 1, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 15, 2020
IMMULITE® 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024
IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025