35 results · 20ms · 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.

MICRO DIARY SPIROMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

ZEUS-O

FDA UDI
SPINAL ELEMENTS·00840916122188·Zeus-O Implant, 10 x 09 x 28mm

Premier

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00856402006214·Decan Stopper Size 6 Closure 3/4

MOBIS 0°

FDA UDI
SIGNUS Medizintechnik GmbH·04047844001660·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587P1009280·10mm PLIF Implant 9mm Wide 28mm Length

RONGEUR LEMPERT CURVED 7 1/2"

FDA UDI
W.H. Holden, Inc.·D9281009280·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587P10092870·10mm PLIF Implant 9mm Wide 28mm Length 7 Degrees

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

PROLITE VL PULSED LIGHT SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)
FDA Class 2 ·Microbiology

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·December 23, 2009

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

COLIBRI

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code MOQ·September 19, 2014

BARD PERFIX PLUG EXTRA LARGE, MONOFILAMENT KNITTED POLYPROPYLENE

FDA Adverse Event
Injury ·DAVOL INC.·Product code FTL·May 18, 2011

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 11, 2012

Angio Pack, part number AMS6711

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

IVEA Product Part Number 16100 Model 500A

FDA Enforcement
Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

FDA Enforcement
Class II ·Terminated·CME America, LLC·December 9, 2020