182 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743694·ACHIMED ACHILLES SUPP SILVER VI
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540602610·Bone Screws, MP, Cross-Pin
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026431·PLATEAU Interbody, Straight, Bulleted, 10mm 20m...
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837009946·
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013
CAROTID WALLSTENT MONORAIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIM·March 16, 2011
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026