23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KAVO CORUND HANDPIECE 2013
FDA 510(k)
FDA Class 2
·Dental
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00271081·
Paragon 28
FDA UDI
Provision·B504OMP9910027080·
XIPHOS ZFUZE
FDA UDI
Difusion Technologies, Inc.·00853896008281·TLIF Spacer 27mm Long x 8mm Height
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746104152·BRACKET NARROW TWIN MAX LEFT LATERAL 022 TQ=+8 ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148912·Straight Implant Trial 27mm x 9mm x 8mm
PROFOX SOFTWARE, MODEL 920M-41
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGICAL DYNAMICS SPINAL RETRACTOR
FDA 510(k)
FDA Class 2
·Orthopedic
UNK
FDA Adverse Event
Malfunction
·THE KENDALL CO·Product code MPB·April 28, 2000
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022
VALVE SET, EM2400
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022
VALVE SET, EM2400
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 13, 2013
UNKNOWN DEPUY FEMORAL COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 17, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·February 26, 2008
250 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021
EXACTA-MIX 2400 COMPOUNDING SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code NEP·February 27, 2023
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 5, 2018
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025