14 results · 21ms · Sources: EU EUDAMED, US FDA

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COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

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

ENDURO MENISCAL COMPONENT F1 10MM

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

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319704202·Castroviejo Suturing Forceps 4" (10cm), w/ 11mm...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694045254·PrimaLIF LLIF PEEK Implant, 9mm X 18mm X 55mm, ...

ANYRIDGE INTERNAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

NICOLET ELECTROCAUTERY DETECTOR

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

RESERVOIR 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

D-TRONPLUS

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

INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·August 8, 2012

KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·August 8, 2012

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