32 results · 23ms · 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.

Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOSURE

FDA UDI
Smith & Nephew, Inc.·03596010559050·GUIDE WIRE 1.2 MM X 12 INCH. BOX ...

Smith and Nephew

FDA UDI
Provision·B504OM72111380·

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551111603·HALO, 1203-5 VEST SMALL, COOLMAX LINER, 1211-1 ...

Savant Lumbar Interbody Fusion System

FDA UDI
CURITEVA, INC.·B648C41432111380·Titanium TLIF Spacer, 32 x 11 x 13mm, 8 deg

Savant Lumbar Interbody Fusion System

FDA UDI
CURITEVA, INC.·B648C40432111380·PEEK TLIF Spacer, 32 x 11 x 13mm, 8 deg

Life Instruments

FDA UDI
Life Instrument Corporation·M93072111383C0·Custom Angled Cobb 3/8" 6" working length

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

Life Instruments

FDA UDI
Life Instrument Corporation·M9307211138110·Custom Angled Cobb 3/8" 6" working legth 5" ALU...

THE PICC WAND (R) PEELABLE SAFETY INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

SMITH MEDICAL JELCO

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC·Product code FMI·April 3, 2024

GUIDE WR 1.2MM X 12 BOX OF 5 STERILE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code LXH·August 19, 2020

6X20MM CALAXO SCREW

FDA Adverse Event
Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·December 21, 2006

7X25MM CALAXO SCREW

FDA Adverse Event
Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·December 21, 2006

7X 20 MM CALAXO SCREW

FDA Adverse Event
Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·December 21, 2006

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 29, 2014

WECK VISISTAT FIXED HEAD SKIN STAPLER, 35W

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code GDT·August 8, 2011

TELIGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

UNKNOWN ENDO GIA SULU

FDA Adverse Event
Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 8, 2022