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