22 results
·
30ms
·
Sources: EU EUDAMED, US FDA
SOFTSEAL HSG CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BiomarC®
FDA UDI
Carbon Medical Technologies, Inc.·00858015005257·Preloaded Carbon Tissue Marker with Enhanced MR...
Equinoxe
FDA UDI
Exactech, Inc.·10885862603227·
Gladstone ALIF Trial Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215045074·
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
FDA 510(k)
FDA Class 2
·General Hospital
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
FDA 510(k)
FDA Class 2
·Microbiology
CONTOUR CURVED CUTTER STAPLER CS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
M-LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·November 21, 2016
M-LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·November 21, 2016
RADICAL-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·February 19, 2016
RAD-57 CONFIGURABLE PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·June 24, 2019
PELVICOL 6 X 8 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·March 18, 2013
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·May 7, 2008
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·April 5, 2011
RAINBOW RC-4
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 11, 2017
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
PROLENE HERNIA SYSTEM UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·March 7, 2019