18 results
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33ms
·
Sources: EU EUDAMED, US FDA
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743564·LEVAMED ANKLE SUPPORT SILVER V
CoRoent
FDA UDI
Nuvasive, Inc.·00887517824738·CoRoent XL Sizer, 15x18x45mm 10°
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909102152·REVELATION DIAMOND 830-012C - 5 PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756350143·HIP PINNING PACK
H.A.M., 15-Channel w/ blank insert holes
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024756·
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110850·TIP GUARDS VENTED WHITE PACK OF 100
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102150·Shaver, Open 15mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023987·PADDLE SPREADER, 15MM
H.A.M.,15-Chan w blank insert holes,Slot
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024763·
STEM: QUADRA-P QUADRA-P SHORT NECK STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 30, 2020
Surgical Gowns
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
PUMP MMT-723RNAS PRDGM INS V2.3 SK EN RC
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·November 22, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 2, 2014
PARKER BATH
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code ILJ·November 23, 2012
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015