31 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.

RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3

FDA 510(k)
FDA Class 2 ·Anesthesiology

STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG

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

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·February 22, 2022

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·February 2, 2022

CADD SOLIS VIP PUMPS

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022

ELONGATED PECTUS STABILIZER

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·May 14, 2013

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 23, 2014

LIGAMAX - CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022

ECHELON

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 25, 2025

MARATHON

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 25, 2025

ONYX

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·July 25, 2025

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·Product code ITX·May 25, 2021

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·April 16, 2024

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·April 2, 2024