18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENTRIMAG RETURN CANNULA KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694052320·.9mm Twist Drill, 8mm STOP, Hex Shank
Fletcher CT/MR Shielded Applicator
FDA UDI
Nucletron B.V.·08717213024205·Fletcher CT/MR Shielded Applicator Set (4 mm)
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819599·Simpson-Murphy Gall Bladder Retractor 2" wide
BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FOZ·June 19, 2023
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515179134·Meyerding Ret, self ret 7 1/2", 80x19mm Custom ...
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INVADER FACTOR V
FDA 510(k)
FDA Class 2
·Hematology
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 20, 2024
BD ANGIOCATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 14, 2024
5MM X 34CM SCISSOR CRTR 10/BOX
FDA Adverse Event
Injury
·APPLIED MEDICAL·Product code LRW·May 8, 2013
HP MBT CEM KEEL PUNCH SZ 4-7
FDA Adverse Event
Malfunction
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LXH·September 23, 2014
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·April 28, 2011
REGENEREX 3 PEG SERIES A PATELLA 31MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 20, 2021
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025