20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ion Endoluminal System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958001925·600 Micron Disposable Diode Laser Lightguide, 6...
Liposuction Cannula
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896108035·Liposuction Cannula With 3 Holes Straight 250 M...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306823831·McKissock Collyer Breast Caliper 30cm
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992011460·LIPOSUCTION CANNULA WITH THREE HOLES STRAIGHT
D/SENSE 1-STEP
FDA 510(k)
FDA Class 2
·Dental
GENYX FLEXIBLE INJECTION NEEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·October 29, 2025
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2011
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWQ·July 2, 2013
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·October 29, 2025
TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 19, 2024
THREE PEG PATELLA 38MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 19, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 22, 2024
NEEDLE SPINAL S/SU 22GA 3IN QUINCKE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·January 14, 2025
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
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