18 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.

VSP SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

WeightRight®

FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020913·Tungsten-Filled Hurst Esophageal Dilator, 56 Fr...

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319704219·Castroviejo Suturing Forceps 4" (10cm), w/ 11mm...

SPONDY SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA

FDA 510(k)
FDA Class 2 ·Radiology

ENDURO MENISCAL COMPONENT F2 22MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014

ENDURO MENISCAL COMPONENT F2 10MM

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018

TM ANKLE TIBIAL INSERT COMPONENT SIZE 4

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018

RESERVOIR 2PK 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 20, 2013

EON MINI IPG, 16-CHANNEL RECHARGEABLE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011

ACCU-CHEK SPIRIT CARTRIDGE

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 13, 2008

TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

ENDURO MENISCAL COMPONENT F1 10MM

FDA Adverse Event
Injury ·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018