19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Q-LUX PLASMA 100 LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00174191·
Sonova Brand
FDA UDI
Sonova AG·07613389477061·myPhonak Junior app
NEOCARE 20 MICRON BLOOD FILTER
FDA 510(k)
FDA Class 2
·General Hospital
TI500 GLOBE-TROTTER TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MONOJET SYRINGE
FDA Adverse Event
Malfunction
·SHERWOOD MEDICAL CO.·Product code FMF·April 25, 1994
MONOJET SYRINGE
FDA Adverse Event
Malfunction
·SHERWOOD MEDICAL CO.·Product code FMF·April 25, 1994
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·August 3, 2024
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·March 11, 2013
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 25, 2011
SOLUSET 150 X 60 BURETTE SET, LATEX FREE
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPK·February 19, 2008
HERO GRAFT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code DSY·August 27, 2015
HEARTWARE VENTRICULAR ASSIST SYSTEM - PATIENT PACK
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·October 13, 2021
Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014
Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP SPONGES PREWASH XRD LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) PAD OBSTETRICAL X-LARGE ST. L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) SYRINGE 20cc SITIP LIF (1) FEEDING TUBE 8FR. 15" LONG (1) BABY BEANNIES LIF (1) DRESSING ISLAND 4" X 14" (1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" L/F (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SUTURE BAG FLORAL LIF (1) UMBILICAL CORD CLAMP (1) BLADE SURGICAL #20 CARBON STEEL (1) WRAPPER 24" X 24" L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024