21 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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E-FIT EF-1280 EMS MACHINE
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814282·GENUMEDI PT SILVER R V
Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm
FDA UDI
SURETEK MEDICAL·B390KM332251·
Brasseler USA
FDA UDI
Provision·00810041064943·
Brasseler USA
FDA UDI
Provision·B504OMKM332250·
NA
FDA UDI
STERILMED, INC.·10888551017114·SAW BLADE MICRO OSCILLATING 9 TEETH/CM STRYKER ...
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
Arthrex®
FDA UDI
ARTHREX, INC.·00888867089105·OSTEOTOME JACK WITH STRIKE PLATE, 25MM
CLYDESDALE PTC SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NYLUS PICC
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 22, 2023
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·October 1, 2014
CONSULTA CRT-P
FDA Adverse Event
Death
·IPG MFG SWITZERLAND·Product code NVZ·May 29, 2013
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 9, 2011
SCISSORS, POINTED, 5 FR., 34 CM
FDA Adverse Event
Malfunction
·KARL STORZ SE & CO. KG·Product code GCJ·July 31, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023