21 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco polycarbonate crowns
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310221043·Safco polycarbonate crowns #10 5/box
Aztec
FDA UDI
Aztecmed/Ent LLC·B87110221040·Bowman Lachrymal Probes, malleable sterling sil...
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540337482·DELTA 2.2X4MM SCREW, 10 EA
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659181403·Cloverleaf plates,104mm/4 holes _x000D_...
Cloverleaf plates,104mm/4 holes
FDA UDI
mahe medical gmbh·EMAH00200221040·Cloverleaf plates,104mm/4 holes
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·May 12, 2022
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NKM·September 30, 2024
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 27, 2014
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·September 30, 2024
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·March 26, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·February 28, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·March 25, 2008
UNKNOWN_NEUWAVE
FDA Adverse Event
Injury
·NEUWAVE MEDICAL, INC.·Product code NEY·November 13, 2024
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FRN·March 21, 2017
General Laparoscopic Tray, Product #TGL33.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code LFL·November 25, 2003
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
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