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

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Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

FDA 510(k)
FDA Class 2 ·Neurology

BD BBL™ Trypticase™ Soy Agar Slants

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902210871·BD BBL™ Trypticase™ Soy Agar Slants

IQ FLEX M

FDA Adverse Event
Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

CAPTURE-R READY INDICATOR CELLS

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·December 23, 2013

HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QUADRA ASSURA CRT-D, DF-4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014

DREAMTOME¿ RX 44

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·August 23, 2011

UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 11, 2013

injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

FDA Enforcement
Class II ·Ongoing·Labories Medical Technologies·May 10, 2023

bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022