23 results · 22ms · 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.

Verifine Safety Type Insulin Pen Needle

FDA 510(k)
FDA Class 2 ·General Hospital

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036034191·

Dilator, Vascular, acc. Geister 15cm 3.0mm alu-handle PURPLE

FDA UDI
Geister Medizintechnik GmbH·04057034046074·Dilator, Vascular, acc. Geister 15cm 3...

Salvo® Spine System

FDA UDI
Spine Wave, Inc.·10840642174670·9.5 x 80 mm Bone Screw, Cannulated, 3 mm Pitch

EXPLOR

FDA UDI
Biomet Orthopedics, LLC·00880304210486·

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869610858·MOSS VRS Ti rod, Ø5.5x65mm, curved

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604109·MOSS Ti Rod, Ø5.5x65mm curved

Dilator, Vascular, acc. Geister 15cm 3.0mm alu-handle PURPLE

FDA UDI
Geister Medizintechnik GmbH·04057034046081·Dilator, Vascular, acc. Geister 15cm 3...

RIVA Posterior Fixation System

FDA UDI
XENIX MEDICAL LLC·00840493415567·Open Lateral Connector, 65mm

SPAULDING IQ ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

CRANIAL STEREOTACTIC EQUIPMENT

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·October 22, 2008

BIOLOX

FDA Adverse Event
Other ·ZIMMER GMBH·Product code LZO·July 25, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 3, 2013

XVWEB

FDA Adverse Event
Injury ·PLANET DDS·Product code LLZ·March 13, 2025

SECOND OPINION

FDA Adverse Event
Injury ·PEARL INC.·Product code MYN·March 13, 2025

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 19, 2023

ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014