15 results
·
29ms
·
Sources: EU EUDAMED, US FDA
SYNCHRON SYSTEMS AMMONIA REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159019049·Jacobson Micro Needle Holder Round Handle
JEL BIOS 90 (CODE NAME RD-2401)
FDA 510(k)
FDA Class 2
·Dental
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
FDA 510(k)
FDA Class 2
·Immunology
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 10, 2025
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 10, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
COLLEAGUE CXE1 PUMP UNREFURB
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·February 28, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2008
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 4, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code BWC·September 4, 2019
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025