19 results
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22ms
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Sources: EU EUDAMED, US FDA
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ForPro
FDA UDI
Tng Worldwide, Inc.·00672047101509·Indigo Nitrile Glove
Size Small
100ct
Biogel
FDA UDI
Bosma Enterprises·10818634023831·Biogel Skinsense Indicator Underglove Surgical ...
BD SAFETY-LOK¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 18, 2018
S-SCAN, MODEL 9800020010
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 24X31X12 LORDOSIS 5°
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·June 7, 2018
SYSTEM, PERITONEAL AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 31, 2013
CONCHATHERM NEPTUNE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL HUDSON RCI·Product code BTT·June 21, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·May 16, 2018
TITANIUM SCREW LOW PROF 5X40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·September 3, 2020
TAPERLOC MICROP FMRL 7.5MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 7, 2020
M2A 38MM MOD HD +12MM NK SKRT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 27, 2020
THINFLAP DOUBLE Y PLATE LONG
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·December 12, 2017
HTR-PMI KOVALIOVAS RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code KKY·December 12, 2017
HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code KKY·December 12, 2017
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS609; 6) STERILE ANGIOGRAPHY PACK, Catalog Number SAN13BS60K; 7) ANGIOGRAPHY PACK, Catalog Number SAN13BS60L; 8) ANGIOGRAPHY PACK, Catalog Number SAN13BS60M; 9) ANGIOGRAPHY PACK, Catalog Number SAN13BS60N; 10) ANGIOGRAPHY PACK, Catalog Number SAN13BS60O; 11) CATH LAB PACK, Catalog Number SAN13CLET2; 12) CATH LAB PACK, Catalog Number SAN13CLETC; 13) CATH LAB PACK, Catalog Number SAN13CLETD; 14) ARTERIOGRAM PACK, Catalog Number SAN21AGE10; 15) ARTERIOGRAM PACK, Catalog Number SAN21AGEG6; 16) ARTERIOGRAM PACK, Catalog Number SAN21AGEG7; 17) ARTERIOGRAM PACK, Catalog Number SAN21AGEG8; 18) ARTERIOGRAM PACK, Catalog Number SAN21AGEG9; 19) ARTERIOGRAM PACK, Catalog Number SAN21AGEGJ; 20) ARTERIOGRAM PACK, Catalog Number SAN21AGEGK; 21) ARTERIOGRAM PACK, Catalog Number SAN21AGEGL; 22) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ10; 23) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ11; 24) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ12; 25) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ13; 26) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ14; 27) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ15; 28) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ16; 29) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ17; 30) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ18; 31) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ19; 32) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC6; 33) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC7; 34) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC8; 35) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC9; 36) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJCH; 37) CVL PACK, Catalog Number SAN22CVW12; 38) CVL PACK, Catalog Number SAN22CVW14; 39) CVL PACK, Catalog Number SAN22CVW15; 40) CVL PACK, Catalog Number SAN22CVW16; 41) CVL PACK, Catalog Number SAN22CVW17; 42) CVL PACK, Catalog Number SAN22CVW18; 43) CVL PACK, Catalog Number SAN22CVW19; 44) CVL PACK, Catalog Number SAN22CVW20; 45) CVL PACK, Catalog Number SAN22CVWRK; 46) CVL PACK, Catalog Number SAN22CVWRL; 47) ACCESSORY PACK, Catalog Number SAN37ASMO3; 48) ACCESSORY PACK, Catalog Number SAN37ASMO4; 49) ACCESSORY PACK, Catalog Number SAN37ASMO5; 50) ACCESSORY PACK, Catalog Number SAN37ASMOE; 51) ACCESSORY PACK, Catalog Number SAN37ASMOF; 52) ACCESSORY PACK, Catalog Number SAN37ASMOG; 53) ACCESSORY PACK, Catalog Number SAN37ASMOH; 54) PEDIATRIC CARDIAC CATH PACK, Catalog Number SAN57PD00K; 55) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS10; 56) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS11; 57) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSM7; 58) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM8; 59) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM9; 60) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSMK; 61) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSML; 62) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSMN; 63) CATH PACK, Catalog Number SAN73CHS10; 64) CATH PACK, Catalog Number SAN73CHS11; 65) CATH PACK, Catalog Number SAN73CHSJ5; 66) CATH PACK, Catalog Number SAN73CHSJ6; 67) CATH PACK, Catalog Number SAN73CHSJ7; 68) CATH PACK, Catalog Number SAN73CHSJ8; 69) CATH PACK, Catalog Number SAN73CHSJ9; 70) CATH PACK, Catalog Number SAN73CHSJJ; 71) CATH PACK, Catalog Number SAN73CHSJK; 72) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSB; 73) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSC; 74) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGR4; 75) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRJ; 76) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRK; 77) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA13; 78) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA14; 79) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA15; 80) ANGIOGRAPHY DRAPE PACK CMC,
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024