15 results · 21ms · Sources: EU EUDAMED, US FDA

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NEBULAE SRS Laparoscopic Surgical Smoke Removal System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776379391·COBB-TYPE ELEVATOR 14" BLADE SIZE 5/8", LIGHTWE...

NA

FDA UDI
DEPUY SPINE, LLC·10705034000831·SPINAL INSTRUMENT LARGE ELEVATOR 15.88mm

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)

NOBELACTIVE TIULTRA NP 3.5X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

NOBELACTIVE TIULTRA NP 3.5X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA

FDA 510(k)
FDA Class 2 ·Immunology

PRECISA BIOPSY NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BLAZER II XP ABLATION CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC, ELECTROPHYSIOLOGY·Product code LPB·October 17, 2008

MAXIMO II CRT-D

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

COULTER® LH 780 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·July 2, 2013

WITTICH NITINOL STONE BASKET

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·February 20, 2019

WITTICH NITINOL STONE BASKET

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·February 20, 2019

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

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025