16 results · 29ms · 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.

AEQUALIS FX2

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517637475·CoRoent Ant TLIF PEEK, 14x11x34mm 15°

Precise

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657008501·Straight Dissecting Forcep, 5mm, 45cm, Standard...

Precise

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657008518·Straight Dissecting Forcep with Ratchet, 5mm, 45cm

Precise

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657075565·Precise Straight Dissecting Forcep, 5mm, 45cm I...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694046541·PrimaLIF LLIF PEEK Implant, 13mm X 26mm X 45mm,...

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181308·Ø4.5mm X 14mm, Fixed Angle Screw, Self-Drilling...

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181315·Ø4.5mm X 16mm, Fixed Angle Screw, Self-Drilling...

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181322·Ø4.5mm X 18mm, Fixed Angle Screw, Self-Drilling...

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181292·Ø4.5mm X 12mm, Fixed Angle Screw, Self-Drilling...

PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES

FDA 510(k)
FDA Class 2 ·General Hospital

WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

LIFEPAK 1000 DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·June 1, 2011

2600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

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