165 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Exsudex Wound Drainage Pump
FDA UDI
Meditop B.V.·08718104890015·The Exsudex® Wound Drainage Device is a compact...
Leksell Stereotactic System
FDA UDI
Elekta Instrument AB·07340048305204·ARC SUPPORT RIGHT
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123799·NobelBiocare™ Tri-Lobe-compatible 6.0 Analog
NEWERA I Wound Drainage Pump
FDA UDI
Meditop B.V.·08718104890053·The Exsudex® Wound Drainage Device is a compact...
CC1 Wound Drainage pump
FDA UDI
Meditop B.V.·08718104890459·The Exsudex® Wound Drainage Device is a compact...
HALO XT Wound Drainage Pump
FDA UDI
Meditop B.V.·08718104890046·The Exsudex® Wound Drainage Device is a compact...
RCI VAK Wound Drainage Pump
FDA UDI
Meditop B.V.·08718104890060·The Exsudex® Wound Drainage Device is a compact...
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
DRAGER SOLA SERIES, MODELS 1000/700/500/300
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Enforcement
Class I
·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123812·NobelBiocare™ Tri-Lobe-compatible 6.0 Analog (2...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123805·NobelBiocare™ Tri-Lobe-compatible 6.0 Analog (1...
FLOCATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAMLOG ROOTFORM IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MAGNESIUM
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JGJ·October 30, 2023
One third tubular locking plate, 133mm/11 holes
FDA UDI
mahe medical gmbh·EMAH10007000110·One third tubular locking plate,
133mm/...
One third tubular locking plate, 97mm/8 holes
FDA UDI
mahe medical gmbh·EMAH10007000080·One third tubular locking plate,
97mm/8...
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993558865·CONFIDENCE 1/CAPRI PANTY BT W. BODY BANDAGE/KNE...
One third tubular locking plate, 49mm/4 holes
FDA UDI
mahe medical gmbh·EMAH10007000040·One third tubular locking plate,
49mm/4...