14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNGO, BREAST CARE
FDA 510(k)
FDA Class 2
·Radiology
VACCESS LT LONG-TERM HEMODIALYSIS CATHETER
FDA UDI
Bard Access Systems, Inc.·00801741010811·VACCESS ST, 14.5 FR. 42cm
AOS TROCHANTERIC NAIL, RIGHT 12.5mm x 42cm x 130°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016680·
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249271·PrimePadPlus-K12-3422
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
FDA 510(k)
FDA Class 2
·Anesthesiology
RNARETAIN
FDA 510(k)
FDA Class 2
·Immunology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·June 14, 2011
OSS DIAPHYSEL SEGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·February 23, 2018
OSS NON-MOD TIB PLATE LONG 67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·March 27, 2018
OSS RS 7 CM MOD SEG FMRL-RT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 27, 2018
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019