19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JET BLUE BITE
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
GEORGE TIEMANN & CO.·B582B58210512430·HOLDER, NEEDLE, GASTROENTEROLOGIC
Dalbo®-S
FDA UDI
Cendres+Métaux SA·07640166513926·Dalbo®-S
Male part C
SEMIAL 5°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844000755·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112430·Awl Tap, 5.5 mm, Fixed Sleeve
DORNIER MEDILAS H
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 19, 2024
UNKNOWN COPELAND SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·April 14, 2017
COPELAND SH HUM SZ4 STND PLUS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·June 8, 2016
UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·October 21, 2016
UNKNOWN COPELAND RESURFACING SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·May 16, 2017
UNKNOWN COPELAND SHOULDER GLENOID COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·July 5, 2017
MEGASUTURECUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 10, 2013
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·April 12, 2011
PUMP MMT-515NAL PRDGM INS V2.1 CL EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·May 22, 2008
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018