32 results
·
33ms
·
Sources: EU EUDAMED, US FDA
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06936735451524·Reusable Pediatric Finger Clip Spo2 Sensor M Te...
PMT Drill Cutter
FDA UDI
adeor Medical AG·04251388961278·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970126·
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
FDA 510(k)
FDA Class 2
·General Hospital
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
TPRLC 133 FP TYPE1 BM HO 10.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 13, 2019
FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·April 16, 2019
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·May 9, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 19, 2014
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 25, 2011
FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 2 130 MM STEM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 25, 2017
FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 25, 2017
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
TI LOW PROFILE SCREW 6.5X20MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·June 14, 2017