22 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MP Pin flat without thread (36BMP000020/MP20)
FDA 510(k)
FDA Class 2
·Dental
ESR-10 Manual Rack
FDA UDI
STRECK, INC.·00844509002123·A 10-position manual Modified Westergren system...
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022746·iFM - Embla
Novaerus NV1050
FDA 510(k)
FDA Class 2
·General Hospital
INITARY BETTER BLADDER-PEDIATRIC
FDA 510(k)
FDA Class 2
·Cardiovascular
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 21, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 22, 2013
MICSAFE MEDICAL GROUP LIMITED
FDA Adverse Event
Malfunction
·ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD·Product code JKA·September 29, 2025
RELI
FDA Adverse Event
Malfunction
·ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.·Product code JKA·July 10, 2024
SINGLE USE GUIDEWIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 1, 2025
VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 27, 2025
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·November 6, 2024
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025