22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040109905·OBTURATOR - OBT20 - SIZE 20 Obt 20pk CHC1
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65820203151·OBTURATOR - OBT20 - SIZE 20 Obt 20pk CHC1
NVM5
FDA UDI
Nuvasive, Inc.·00887517206657·NVM5 Module, SSEP
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103148·Midway Select Disposable Diamonds 856-018SC, Pk...
PRETIUM CANADA PACKAGING ULC
FDA registration
PRETIUM CANADA PACKAGING ULC·8 products·🇨🇦 Canada
WISEBANDS SKIN CLOSURE DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VENTRICULAR ANALYSIS TOOLKIT OPTION
FDA 510(k)
FDA Class 2
·Radiology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 27, 2019
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862199522·
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
HEAD/NECK 26 STRETCH OBS1/00
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 25, 2013
ESSURE
FDA Adverse Event
Other
·BAYER PHARMA AG·Product code HHS·March 11, 2011
PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·March 26, 2008
HOMEPUMP C-SERIES 270ML, 5ML/HR
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code MEB·July 22, 2015
HOMEPUMP C-SERIES 270ML, 5ML/HR
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code MEB·August 14, 2015
SYNERGY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·October 14, 2020
SYNERGY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·October 14, 2020
SYNERGY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·October 14, 2020
SYNERGY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·October 14, 2020