19 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.

BeneLife Premium Facial Treatment Pack, Model: QZ0701A

FDA 510(k)
FDA Class 2 ·Neurology

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506075469·2PC SHUNT PERITONEAL CATHETER PASSER W/ SMALL R...

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500

FDA 510(k)
FDA Class 2 ·Cardiovascular

C2 NERVEMONITOR SYSTEM WITH ACCESSORIES

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 17, 2024

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011

AIM-ARM F/AFN

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code FZX·June 15, 2013

PERFORATOR DRIVER WITH HUDSON END

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 14, 2014

UNK - INSERTION INSTRUMENTS

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·September 15, 2020

UNK - CAGE/SPACERS: ACIS

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code ODP·September 15, 2020

UNK - INSERTION INSTRUMENTS

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·September 15, 2020

INNER SHAFT-STANDARD FOR ACIS IMPLANT INSERTER

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·September 15, 2020

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021