15 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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GALEMED PEAK FLOW METER, MODELS 3751/3752
FDA 510(k)
FDA Class 2
·Anesthesiology
OCTAGON Infinity BL RC ALLIGATOR Abutment GH 1.0 mm
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50221241·BL RC ALLIGATOR Abutment GH 1.0 mm for OCTAGON ...
BD BLUNT FILL NEEDLE WITH FILTER
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·August 6, 2021
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
FDA 510(k)
FDA Class 2
·Radiology
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·September 7, 2022
G7 HI-WALL E1 LINER 36MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·March 28, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 10, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·March 25, 2008
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
FDA Enforcement
Class II
·Terminated·Tedan Surgical Innovations Llc·September 26, 2012
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2018
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018