22 results · 36ms · 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.

MHS 7000

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

AOS CORTICAL LOCKING SCREW 2.7mm x 18mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009224·

Bone Screws

FDA UDI
ORTHOPEDIATRICS CORP.·00841132133972·4.0 SCREW SYSTEM CASE SCREW CADDY

Vermed

FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·00009336008230·Din Lead Wire .080, Snap to Socket, 18", White

Vermed

FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·00009336008223·Din Lead Wire .080, Snap to Socket, 18", Red

Citrelock ACL 8mm Sizing Tube

FDA UDI
Acuitive Technologies, Inc.·00810027271587·

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·May 3, 2023

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 6, 2019

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710310300180·Talar Osteotmy Guide, 30mm x 18mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710820300180·Zadik Calcaneal Guide, 30mm x 18°

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710300300180·Tibial Osteotmy Guide, 30mm x 18mm

TITAN TIBIAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

BRANEMARK NOVUM

FDA 510(k)
FDA Class 2 ·Dental

ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code BSP·November 21, 2019

APPLICAT OUT SHAFT

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code LXH·April 2, 2013

TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·March 25, 2011

ACCU-CHEK RAPID D INFUSION SET

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·April 14, 2008

ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·July 5, 2023

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

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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