18 results · 21ms · 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.

FLASH BITE

FDA 510(k)
FDA Class 2 ·Dental

CoRoent

FDA UDI
Nuvasive, Inc.·00887517574855·CoRoent Ant TLIF Ti, 13x13x40mm 0°

DreamWear Full

FDA UDI
Respironics, Inc.·00606959045897·DreamWear Full Mask with Medium Frame, with Hea...

N/A

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138104549·NEOPRENE THUMB SPICA, UNIV

SCHWERT

FDA UDI
A. Schweickhardt GmbH & Co. KG·E89611334000·Scissors, LA GRANGE SuperCut 11,5cm...

WESTCOTT TENOTOMY SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014541·WESTCOTT TENOTOMY SCISSORS CURVED BLUNT BLADES

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702930511·ELVAREX FORTE 3/KNEE HIGH/CLOSED TOE-ELEPHANTIA...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702251623·Elvarex 2/Thigh High/Profile, Slant, Closed Toe...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702595857·E2/AD/CT/SFT/BLU

FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP

FDA 510(k)
FDA Class 2 ·Neurology

SENO ADVANTAGE

FDA 510(k)
FDA Class 2 ·Radiology

ROCCIA

FDA UDI
Silony Medical GmbH·04054896028774·ROCCIA MultiLIF Cage 13x34 mm, 0° Lor.

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 29, 2013

UNKNOWN DEPUY CEMENT

FDA Adverse Event
Injury ·DEPUY CMW·Product code LOD·June 13, 2011

ALARIS PUMP MODULE

FDA Adverse Event
Injury ·CAREFUSION·Product code FRN·September 25, 2015

Philips Respironics DreamWear Full Face Mask

FDA Enforcement
Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015