137 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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MAGNA 5000 PHASED ARRAY CTL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994989895·CANNULA 2000002 INSERTER 9MM
Assure® Slide Pill Swallowing Aid forte
FDA UDI
ARKRAY USA, INC.·00015482100025·Assure Slide Pill Swallowing Aid is for people ...
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950023493·RONGEUR #1A 6-1/2 16.5CM
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·September 29, 2023
WINDSOR MEDICAL MODEL 50-00002
FDA 510(k)
FDA Class 2
·General Hospital
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·November 22, 2023
DYNATECH SPD 3000, #002-900-0000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SILVERVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948034639·SILVERVENT LINGO-PHON 1 ICF, SIZE 2
Jade
FDA UDI
DHARMA RESEARCH, INC.·00353045000635·Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x...
Rhinostics, Inc.
FDA UDI
Rhinostics Inc·00850042963074·Rhinostics Transport Tube (clear)
Remote Control Accessory
FDA UDI
Novasignal Corp.·00850681007047·The Remote Control Accessory is an optional acc...
CareSens
FDA UDI
i-SENS, Inc.·00885325000542·CareSens Lancet (100T/Pack)
Sequel Medical
FDA UDI
Sequel Medical Inc.·00810071321146·6 Tab Full Ring 200mm
n/a
FDA UDI
Ortho Development Corporation·00822409071654·Stem Inserter, Long Tip
SILVERVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948000016·SILVERVENT 1 IC, SIZE 2
AVOSET 100ML CASSETTE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·January 21, 2026
MICROBORE TUBING
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·January 21, 2026
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery