21 results · 33ms · Sources: EU EUDAMED, 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