22 results · 22ms · Sources: EU EUDAMED, 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