10 results · 25ms · 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.

MICROSCOPE

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

EasyTouch

FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18225612·ET 25G 1 in 3mL Low Dead Space FlipLock Syr

Tranquil-L™

FDA UDI
NEXUS SPINE, L.L.C.·B6788225610·Steerable IBD Trial 13x10x32, 6 deg

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000

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

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

TALENT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 27, 2010

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022