18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
RMO
FDA UDI
Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST
TruForm
FDA UDI
Rmo, Inc.·00885797099983·MN 1MOL BD KT STD N/L UNIV 218
Comfort Short™ cannula
FDA UDI
Unomedical A/S·05705244003118·Single use infusion cannula for subcutaneous in...
neria™soft cannula
FDA UDI
Unomedical A/S·05705244001091·Single use infusion cannula for subcutaneous in...
PAK12
FDA Adverse Event
Malfunction
·IMMUCOR GTI DIAGNOSTICS, INC.·Product code MYP·September 15, 2015
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
FDA 510(k)
FDA Class 2
·Dental
TREPCHEK TREPONEMAL ANTIBODY EIA
FDA 510(k)
FDA Class 2
·Microbiology
COBAS U 601 URINE ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code KQO·January 30, 2026
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2022
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 13, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·February 28, 2011
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 9, 2008
ZIMMER AIR DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·August 19, 2025
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024