22 results
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20ms
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Sources: EU EUDAMED, US FDA
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