16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
FDA 510(k)
FDA Unclassified
·Unknown
Mizzy
FDA UDI
Keystone Industries·H66860705201·ZOE Cement Kit 21g pwd, 7.5 liq
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114694575·Digital Analog for Lab, SP, inc. Screw
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345027244·Inserter, 11-16MM, Lumbar Straight
StrykeFlow
FDA UDI
STRYKER CORPORATION·07613327061369·2, Disposable Suction/Irrigator with Disposable...
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C-IT
FDA 510(k)
FDA Class 2
·Anesthesiology
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 9, 2024
MESH, SURGICAL
FDA Adverse Event
Injury
·W. L. GORE AND ASSOCIATES, INC.·Product code FTM·August 12, 2023
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 3, 2025
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 17, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 29, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 7, 2008
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
FDA Recall
Terminated
·Stryker Endoscopy·Product code GCX·November 18, 2005
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024