36 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANYPLUS PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827882·***DISC*LEVAMED ANKLE SUPPORT BLACK VI
COOLEY PEDIATRIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921005160·COOLEY PEDIATRIC VASCULAR CLAMP DELICATE ANGLED
COOLEY PEDIATRIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896010321·COOLEY PEDIATRIC VASCULAR CLAMP DELICATE ANGLED
HS Diam. Burr, Ø1.4x70, 50k
FDA UDI
Bien-Air Surgery SA·07630055506573·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319702437·Lister Bandage Scissors 7-1/4" (18.1cm), side a...
Admiral
FDA UDI
Seaspine Orthopedics Corporation·10889981304799·Temporary Fixation Screw
Arena-L®
FDA UDI
SPINEFRONTIER, INC.·00190361005469·Arena-L, Lordotic 10 degrees, 35X26X16
REMSTAR AUTO A-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 29, 2025
GE LOGIQ 700
FDA 510(k)
FDA Class 2
·Radiology
ADVANTA SST GRAFT (>_6MM)
FDA 510(k)
FDA Class 2
·Cardiovascular
PAXGENE BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 24, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
NEXGEN CR-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·May 17, 2011
MICROCLAVE CLEAR CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·June 5, 2014
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·December 14, 2022
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·March 9, 2016