22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004028·PowerChem Neoprene Exam Gloves, Small
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105626·PowerChem Neoprene Exam Gloves, Small
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113424·CRESCENT KNIFE BEVEL UP (BX/5)
MEDALLION MODULAR HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304639980·
4.0 X 24mm CANN SCREW FASTENER Ti LG THD
FDA UDI
Osteocentric Technologies, Inc.·00810074303453·4.0 X 24mm CANN SCREW FASTENER Ti LG THD
SUREFIT DISPERSIVE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
FDA 510(k)
FDA Unclassified
·Unknown
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010
SILICONE BREAST IMPLANT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FTR·June 8, 1994
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·March 8, 2013
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·January 28, 2011
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 9, 2014
DELTA CER FM HD 032/-4.0 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 17, 2023
MICRO TAPERLC LAT PC 9MM 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 17, 2023
UNKNOWN HIP FEMORAL CONSTRUCT SUMMIT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LZO·May 17, 2025
SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code MAX·March 19, 2012
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024