16 results
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32ms
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Sources: EU EUDAMED, US FDA
ADG BONE PLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Synergy
FDA UDI
Rmo, Inc.·00885797101075·RMO(R) SYNERGY(R) BIOPROGRESSIVE H KIT .018 HK ...
Synergy
FDA UDI
Rmo, Inc.·00885797672988·SYN BIO H .018 HK345 MN LOW IN/OUT CUSP 5-5
ALLthread Titanium
FDA UDI
Biomet Orthopedics, LLC·00880304464896·
Panther®
FDA UDI
Hologic, Inc.·15420045504141·Panther® Instrument System.
WIRELESS DR IMAGING OPTION-WDR1
FDA 510(k)
FDA Class 2
·Radiology
SURGICAL SYSTEM WITH CRYOGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 30, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 18, 2010
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
FDA Recall
Terminated
·Hologic, Inc·Product code NSU·September 15, 2017
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
FDA Enforcement
Class II
·Terminated·Hologic, Inc·October 25, 2017
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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