66 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT
FDA 510(k)
FDA Class 2
·Ophthalmic
PureGuard
FDA UDI
PURELIFE, LLC·D79010240031·Medium, Soft, nitrile powder-free, Textured fin...
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751804·Sterile Single Use Burs - ISO Code 859-017F
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140030·Cap Starter, T30, Split Tip, Quarter Square
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0140030·Counter Torque, Tower Tab
MONTANE ALPS M-P7.F0 [SZER 69 CM] US
FDA UDI
MEDEN INMED SP Z O O·05903684802258·The MONTANE treatment table is a treatment tabl...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197470841·Farrior Aural Speculum, round
Ø 7.5m...
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
FDA 510(k)
FDA Class 2
·Cardiovascular
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014
TRANSDUCER, S8 3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014
TRANSDUCER S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014
UNK LIQUID EMBOLIC
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KGG·May 28, 2026
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 27, 2013
SMARTPUMP DUAL CHANNEL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KCY·February 14, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code NGY·April 29, 2009
PHASITRON BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·PERCUSSIONAIRE CORP.·Product code CBK·February 28, 2025