15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112663·BARRON CORNEAL PUNCH 8.75MM
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
FDA 510(k)
FDA Class 1
·General Hospital
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM
ENDOSCOPIC CLIP SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUWAVE Microwave Ablation System and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·October 27, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
ECHELON
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·December 22, 2022
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·June 12, 2012
INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 24, 2024
ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 4, 2021
PHASIX MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code OOD·October 12, 2023
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016