17 results · 27ms · Sources: EU EUDAMED, US FDA

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SMV Scientific Bone Screws

FDA 510(k)
FDA Class 2 ·Orthopedic

HHM

FDA UDI
Oticon A/S·05707131282545·H110V2, BTE 13 WL 85 TC HHM

ORTHODONTIC INSTRUMENTS

FDA UDI
Ortho Organizers, Inc.·00190707064754·DOUBLE-ENDED EXPLORER INSTRUMENT

BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 30, 2017

UNITED STEM, PSA TYPE

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INFANT CONTINUOUS FLOW BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 6, 2013

HIP HEAD, 10/12 TAPER,28MM,+5MM

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 29, 2011

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 28, 2008

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

NESTER PLATINUM EMBOLIZATION MICROCOIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

STAINLESS STEEL EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·August 24, 2017

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015