31 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PATIENT MONITOR, MODEL PM50
FDA 510(k)
FDA Class 2
·Cardiovascular
ALGO 7i Set 1
FDA UDI
PATH medical GmbH·04260223145421·ALGO 7i Base Kit containing:
1x 101049 ALGO 7i
...
TeleRehab Receiver Box
FDA UDI
SCOTTCARE CORPORATION, THE·00856298006282·The housing used to enclose RF receiver cards f...
NeoGuard™
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436102179·Non-sterile (2.0 x 30cm) cover
CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127
FDA 510(k)
FDA Class 1
·Hematology
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
FDA 510(k)
FDA Class 2
·Immunology
ELI 230 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
DELTAFILL18 8MM X 35CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 4, 2016
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 7, 2011
CURRENT PLUS DR, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
RESPIRONICS INC·Product code BTI·September 19, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 24, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·October 6, 2023
REFLEX CATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·March 30, 2026
REFLEX CATHETER
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·March 30, 2026
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·May 8, 2013
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·August 8, 2012