21 results
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18ms
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Sources: EU EUDAMED, US FDA
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
FDA 510(k)
FDA Class 2
·Physical Medicine
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964019706·Endo Carry-On Procedure Kit
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00262161·
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752115118·AirLife™ Mini Cushion Nasal Cannula With 7 foot...
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967189093·Battalion, LLIF Trial, 0°, 26 mm Wide, 16 mm X ...
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF20026160·3.0mm Cannulated Screw, Self-Drilling, Short Th...
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746103506·BRACKET NARROW TWIN MAND LEFT CUSPID 022 TQ=0 A...
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 26, 1997
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
FDA 510(k)
FDA Class 2
·General Hospital
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·March 13, 2013
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL INC·Product code MKJ·February 8, 2011
2100 ML LINER W/EXTERNAL VALVE
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·February 8, 2008
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50" X 90" UF Product Usage: 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
Shoulder Pack, catalog #900-2616 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
Shoulder Pack, catalog #900-2616 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 OJH·October 8, 2014
SHOULDER PACK 6/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
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50" X 90" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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