33 results · 22ms · Sources: EU EUDAMED, US FDA

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NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

FDA 510(k)
FDA Class 2 ·Cardiovascular

PowerGlide Midline Catheter

FDA UDI
Bard Access Systems, Inc.·00801741038068·DOT PGlide 20G 8cm Full

Peripheral Catheter Insertion Kit

FDA UDI
Bard Access Systems, Inc.·00801741110573·DOT PFlex, 20G 8cm Full

EVO 2 ST

FDA UDI
DENTAL MANUFACTURING SPA·08056865012810·

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK1200110·Rod Gripper, 5.50mm Angled

ENDOSCOPIC CLIP SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ENTEROSCOPY OVERTUBE, MODEL 00712140

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

POWERGLIDE MIDLINE CATHETER

FDA Adverse Event
Malfunction ·BARD ACCESS SYSTEMS, INC.·Product code FOZ·September 8, 2014

Widex

FDA UDI
Widex A/S·05706069794427·Widex EVOKE E-FP (Tan silk ) 220, Telecoil, Vol...

Widex

FDA UDI
Widex A/S·05706069817799·Widex UNIQUE U-FM (Tan silk ) 220, RC coil

Widex

FDA UDI
Widex A/S·05706069806298·Widex EVOKE E-FA (Tan silk ) 220, Telecoil, Vol...

Widex

FDA UDI
Widex A/S·05706069807332·Widex EVOKE E-FM (Tan silk ) 220, RC coil

Widex

FDA UDI
Widex A/S·05706069817249·Widex UNIQUE U-FA (Tan silk ) 220, Telecoil, Vo...

Widex

FDA UDI
Widex A/S·05706069818147·Widex UNIQUE U-FP (Tan silk ) 220, Telecoil, Vo...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

VANG SSK INTLK FEM 65 RT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·May 20, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

CAPTURE-R READY SREEN I AND II

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·June 10, 2011

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

FDA Enforcement
Class II ·Terminated·Bard Access Systems·March 25, 2015

MONOSYN UNDYED 5/0 OR 6/0

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021