21 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZOLL Propaq M
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113394·MICS TRAP KNIFE 1.8/2.2 (BX/5)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112601·BARRON CORNEAL PUNCH 7.25MM
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184155·Accufit Molar Bands Lower Left Second Molar 37 1/2
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LUCIA
FDA 510(k)
FDA Class 2
·Physical Medicine
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·April 24, 2024
TUNGSTEN CARBIDE METAL TRIMMING BUR
FDA Adverse Event
Injury
·DENTSPLY MAILLEFER·Product code EJL·August 3, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 2, 2013
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·August 28, 2023
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 6, 2023
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 6, 2023
PROXIMATE*PPH PROCEDURE SET
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 6, 2023
PROXIMATE*PPH PROCEDURE SET
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 6, 2023
RHA 3
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·May 3, 2023
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