22 results · 20ms · Sources: EU EUDAMED, US FDA

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3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

18M - Class A 21 White Cap - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588620091·18M - Class A 21 White Cap - Metal

OsteoMed

FDA UDI
OSTEOMED LLC·00845694018579·2.0mm x 9mm Lag Screw

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193107080·HA PEEK EVOS Straight, ,9mmx9mmx 22mm , BICONVE...

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710460220090·Lateral Guide, Closing Wedge Osteotomy, 22mm x 9mm

OsteoMed

FDA UDI
OSTEOMED LLC·00845694066426·HPS 2.0 x 9mm Lag Screw Sterile Qty 5

MX8000 IDT CT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

HP M2376A DEVICE LINK SYSTEM, MODEL M2376A

FDA 510(k)
FDA Class 2 ·Cardiovascular

PINNACLE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTP·November 14, 2022

HAMILTON MEDICAL AG

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·November 14, 2023

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·March 26, 2013

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·March 10, 2011

ENDO GIA ROTICULATOR 60- 4.8 SULU

FDA Adverse Event
Injury ·NORTH HAVEN - USS·Product code GAG·March 31, 2008

Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

FDA Recall
Open, Classified ·Owens & Minor Distribution, Inc.·Product code FYA·October 31, 2022

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24

FDA Enforcement
Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

NEEDLE 19GA 1IN TW

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 26, 2020

BD ALARIS¿ SMARTSITE¿ EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 2023

ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code FOZ·October 25, 2022

Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.

FDA Recall
Terminated ·C.R. Bard, Inc., Urological Division·Product code FPA·April 2, 2009

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures

FDA Enforcement
Class II ·Terminated·Acumed LLC·May 7, 2014