24 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMP IT
FDA 510(k)
FDA Class 2
·Dental
Bur PM2-70 cranial spiral 25mm sterile
FDA UDI
Bien-Air Surgery SA·J00711004130011·
Bur Cranial Spiral 25mm St
FDA UDI
Bien-Air Surgery SA·17630055503708·
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707045036·012 SHORTY KOBY TWISTS
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319702307·O'Brien Stitch Removal Scissors 3-3/4" (9.4cm),...
Symmetry Collier
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482054321·Ultra Instruments Needle Holder; Collier; Serra...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450025857·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450018736·
inset™II
FDA UDI
Unomedical A/S·05705244007932·Single use infusion set for subcutaneous infusi...
Bicon Impression Component
FDA UDI
BICON, LLC·00813110023650·2.5mm Two-Part Titanium Impression Post and Pla...
inset™II
FDA UDI
Unomedical A/S·05705244007956·Single use infusion set for subcutaneous infusi...
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
FDA 510(k)
FDA Class 2
·Cardiovascular
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 10, 2020
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 8, 2013
LAG SCREW, TI GAMMA3® Ø10.5X95MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·September 19, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2011
Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·September 29, 2009
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 22, 2018