23 results · 24ms · 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.

GenesisZr UHT700 Zirconia

FDA 510(k)
FDA Class 2 ·Dental

EarQ

FDA UDI
Oticon A/S·05707131356727·G40 S, MINIRITE R LI-ION 2.4G C093 EARQ

7450 RV2 MASK

FDA UDI
HANS RUDOLPH, INC.·00874750004300·RV2 MEDIUM MASK BRACE SET

ABSORBENT PAPER POINTS

FDA UDI
DiaDent Group International·08806383554466·"An absorbent paper points is an endodontic pap...

Aria Stem Size 8 Template

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215056193·

ABSORBENT PAPER POINTS

FDA UDI
DiaDent Group International·08806383512428·"An absorbent paper points is an endodontic pap...

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·March 8, 2012

SMITHWICK CAROTID SHUNT

FDA 510(k)
FDA Class 2 ·Cardiovascular

BLAINE SCARCARE PATCH

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

MINIMED QUICK-SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 16, 2025

HAMILTON-C6

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025

Fortilink Cages with TiPlus Technology

FDA UDI
Baat Medical Products B.V.·08720246784930·

Fortilink Cages with TiPlus Technology

FDA UDI
Baat Medical Products B.V.·08720246789485·

Fortilink Cages with TiPlus Technology

FDA UDI
Baat Medical Products B.V.·08720246785005·

Fortilink Cages with TiPlus Technology

FDA UDI
Baat Medical Products B.V.·08720246789553·

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

FDA Enforcement
Class II ·Terminated·Arrow International Inc·December 18, 2013

Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring

FDA Enforcement
Class II ·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016