22 results · 21ms · Sources: EU EUDAMED, 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