21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
FDA 510(k)
FDA Class 1
·Dental
WISP
FDA UDI
Respironics, Inc.·00606959039902·SM Wisp Mask, Clear Frame, without Headgear, Sm...
Tasso+
FDA UDI
Tasso Inc.·00860006434595·
Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436122877·Sterile TP Pivot Pro™ transperineal needle guid...
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK
ORLOCATE SYSTEM MODEL ORL 100
FDA 510(k)
FDA Class 1
·General Hospital
SURE CHECK PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 14, 2023
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·January 26, 2011
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·April 24, 2008
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·April 30, 2013
COMPACT AIR DRIVE II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 19, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·May 20, 2011
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·April 24, 2008
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 27, 2012
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013