22 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511

FDA 510(k)
FDA Class 2 ·Anesthesiology

APC™ II Unitek™ Mini Uni-Twin

FDA UDI
3M UNITEK CORPORATION·00652221062048·Mini Uni-Twin(TM) Bracket APC(TM) II UL1 17T/5A...

APC™ PLUS Unitek™ Mini Uni-Twin

FDA UDI
3M UNITEK CORPORATION·00652221093066·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL1 17T/...

3M™ Unitek™ Uni-Twin™

FDA UDI
3M UNITEK CORPORATION·00652221016133·Mini Uni-Twin(TM) Bracket UL1 17T/5A .018 5/Pk

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450157695·

PROMA, INC.

FDA registration
PROMA, INC.·2 products·🇺🇸 United States

BRACHYSEED

FDA 510(k)
FDA Class 2 ·Radiology

REPLACE TPS COATED IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

BERLIN HEART EXCOR PEDIATRIC VAD

FDA Adverse Event
Injury ·BERLIN HEART GMBH·Product code DSQ·June 17, 2021

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 16, 2011

SETROX S 53

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008

BD PRECISIONGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·April 8, 2021

NEEDLE 30X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 29, 2021

BD PRECISIONGLIDE¿ NEEDLES

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 13, 2023

PEN NEEDLE AUTOSHIELD DUO 30GX5MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 9, 2021

BD PRECISIONGLIDE¿ NEEDLES

FDA Adverse Event
Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 31, 2023

NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 18, 2019

BD PRECISIONGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 31, 2019

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024