23 results · 23ms · Sources: EU EUDAMED, US FDA

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SITE-RITE VISION ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Bur PM2-70 80K Carb Ø4.5 St

FDA UDI
Bien-Air Surgery SA·17630055503661·

GLOVER COOLEY BULLDOG CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002180·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED CURVED

GLOVER COOLEY BULLDOG CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004020·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED CURVED

OsteoMed

FDA UDI
OSTEOMED LLC·00845694089319·ISO Chin Plate, 10mm

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604925·MOSS 100 Rod Holding Forceps Ø5.5mm 270mm

BIPAP AUTO BIFLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 30, 2025

SMOOTH-FLO CIRCUIT

FDA 510(k)
FDA Class 2 ·Anesthesiology

SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST

FDA 510(k)
FDA Unclassified ·Unknown

VENTED AUTOFEED CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 8, 2011

AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 2, 2011

MAQUET HCU30 DEVICE

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWC·July 29, 2015

HEYER-SCHULTE MAMMARY PROSTHESIS

FDA Adverse Event
V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FTR·November 16, 1994

OLYMPUS COLONOSCOPE

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code MNL·September 9, 2022

COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025

RESTORE SENSOR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

8800

FDA Adverse Event
Malfunction ·GE MED SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011

Microdot Xtra blood glucose test strips

FDA Enforcement
Class II ·Ongoing·Cambridge Sensors Limited·August 28, 2019

Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number 8100402 size 3,item number 8100040 size 4, item number 8100041 size 5, item number 8100229 size 6, item number 8100322 size 7, item number 8100374 size 8, item number 8100282 size 9, and item number 8100709 size10.

FDA Recall
Terminated ·Premier Dental Products Co·Product code JOH·August 5, 2004