24 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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FASTPACK TESTO IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Oticon
FDA UDI
Oticon A/S·05707131163721·K14, MINIRITE SGR
SERIES TWENTY THOUSAND LEGACY
FDA Adverse Event
Injury
·ALCON LABORATORIES, INC·Product code HQE·September 18, 1996
DATA MASTER PERFUSION MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ZOLL PAD
FDA 510(k)
FDA Class 3
·Cardiovascular
DELTA-TT ACETAB.CUP
FDA Adverse Event
Malfunction
·LIMACORPORATE SPA·Product code LPH·May 21, 2018
QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·August 5, 2013
NEXGEN LPS-FLEX STEMMED TIBIAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code NJL·September 24, 2015
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
AZURE XT DR MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC EUROPE SARL·Product code NVZ·August 12, 2024
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021