50 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OralTox Oral Fluid Drug Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383552547·Gutta Percha Points is used to root canal filin...
Life Instruments
FDA UDI
Life Instrument Corporation·M93071714030T10·14" Thoracic Curette #3 Str w/teeth 5" handle
ELI 250 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·February 22, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
FRAXEL SR 1500 LASER SYSTEM
FDA Adverse Event
Injury
·RELIANT TECHNOLOGIES, INC.·Product code GEX·February 22, 2007
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.,·Product code LGW·September 17, 2008
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 7, 2021
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·September 28, 2023
ULTRATHANE AMPLATZ URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·September 11, 2020
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 22, 2020
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 16, 2020
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·May 5, 2022
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·August 31, 2022