22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
FDA 510(k)
FDA Class 2
·Physical Medicine
PowerPICC Provena SOLO
FDA UDI
Bard Access Systems, Inc.·00801741232046·Catheter Placement Kit
X-MARK Ultra
FDA UDI
Izi Medical Products, LLC·B8870010790·0.85mm x 3cm X-MARK Ultra Preloaded
Runnels Steerable Introducer™ #5 Nasal
FDA UDI
Through The Cords, LLC·00850059297001·Pre-lubricated articulating introducer with int...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001079·artVeneer life upper anteriors, IXL, A3
GentleMax LE Delivery System W/DCD
FDA UDI
Candela Corporation·00817495021270·Delivery System Assembly
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Coveris
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS0010790·12mm x 14.5mm Lordotic 3°, 11mm
NeuroProbe
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290016450385·
Sterile neuroprobe
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290114061834·
NeuroProbe
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290014954380·
AIRCAL 200, 1079
FDA Adverse Event
Injury
·NATUS SENSORY IRELAND·Product code KHH·May 18, 2026
AIRCAL 200, 1079
FDA Adverse Event
Malfunction
·NATUS MEDICAL DENMARK (GN OTOMETRICS)·Product code KHH·September 2, 2019
VORTEK SINGLE LOOP URETERAL STENT
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FAD·March 14, 2023
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·February 16, 2011
MALLINCKRODT
FDA Adverse Event
Injury
·HENEQUEN·Product code BTR·February 22, 2008
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
FDA Enforcement
Class II
·Terminated·Nipro Diagnostics, Inc.·February 12, 2014
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025