21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMMA3 NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034002·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...
NIFometer
FDA UDI
MERCURY ENTERPRISES, INC.·10641043340028·
4.0 X 30MM DRILL SLEEVE
FDA UDI
Osteocentric Technologies, Inc.·00816950029721·4.0 X 30MM DRILL SLEEVE
pjur Aqua
FDA UDI
Pjur Group Luxembourg SA·00827160110086·Water-based Personal Lubricant
K034020
FDA Adverse Event
Injury
·C.R. BARD, INC. (BASD)·Product code LJS·November 16, 2007
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024367333·Heel Rest, 13 cm
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·June 10, 2022
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 3, 2013
UNKNOWN DEPUY SIZE 2 RT POROUS COATED FEMUR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 17, 2011
SJM EPIC STENTED TISSUE VALVE
FDA Adverse Event
Injury
·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·April 25, 2008
PLUM LS PRIM. 225 CM CLAVE PORT DISTA
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012