12 results
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20ms
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Sources: EU EUDAMED, US FDA
QUANTRX FEMALE FERTILITY TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
StrykeFlow
FDA UDI
STRYKER CORPORATION·07613327052039·Reusable Suction Irrigation Tip, Standard, Vent...
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 28, 2025
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CARESIDE LDH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARTRIDGE
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 22, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 29, 2011
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 7, 2008
Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·May 15, 2013
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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