18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WALLACH LOOP ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827899·ACHIMED ACHILLES SUPP BLACK I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221231420·Unitek Miniature Twin MBT LR Cus 0T/3A DHk 022 ...
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837050757·10mmx20mmx11mm Plateau-P, 7 Degree Reverse Angle
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837009892·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837009991·
ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
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
K 520711-2, Hercep Test, 35Test, HER2, Protein
FDA Recall
Terminated
·Dakocytomation California Inc·Product code MVC·September 29, 2005
HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE, 2.5MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·March 18, 2013
MACH1 GUIDE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·March 16, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 15, 2020
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·September 16, 2021
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014