21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Medi-First Plus Flexible Large Patch HW
FDA UDI
Medique Products·00347682106737·A flexible patch of fabric material, coated on...
HOHMANN ELEVATOR RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049451·HOHMANN ELEVATOR RETRACTOR
NITANIUM® SUPER ELASTIC ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707059958·.020 X .020 LOWER NITANIUM® SUPER ELASTIC PRO F...
Monoblock Tibial Trial PS Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042738·
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494462290·Hook Probe Square Handle Steel
D 3.0mm, WL 310mm
23G ETW X 7MM PEN NEEDLE US
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·April 29, 2020
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRANSVENE CS/SVC LEAD
FDA Adverse Event
Injury
·MPRI·Product code LWS·July 6, 2025
COBALT¿ HF QUAD CRT-D MRI SURESCAN¿
FDA Adverse Event
Malfunction
·MEDTRONIC EUROPE SARL·Product code NIK·February 16, 2026
CAPSUREFIX NOVUS MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·April 8, 2025
COBALT¿ XT HF CRT-D MRI SURESCAN¿
FDA Adverse Event
Injury
·MEDTRONIC EUROPE SARL·Product code NIK·February 24, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·May 12, 2011
CLARIA MRI CRT-D SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC EUROPE SARL·Product code NIK·September 22, 2023
M2A-38 60MM CUP NON FLARED
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 24, 2012
Alinity m System, Part No. 08N53-002
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·January 12, 2022
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