15 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
KeyPrint
FDA UDI
Keystone Industries·H66842201551·KeySplint Soft Clear for Carbon 1 kg
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780381730·Integra® Jarit® Wolfe-Boehler Cast Breaker, 10-...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112908·CORNEAL TREPHINE BLADE7.25MM
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361035985·FENESTRATED SCREW, CANNULATED, Ø10MM x 55MM, SA...
TriVerse Femoral Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097837·
LINK Instruments - Saw and drill guides
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575341429·Orthopaedic implant aiming/guiding block, reusa...
DYNA-LOK CLASSIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHREX KNOTLESS SUTURETAK ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIOVUE METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2016
OPTIFLOW JUNIOR INTERFACE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·November 3, 2014
VS3 MONITOR W/NIBP
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MHX·August 8, 2011
PROMOTE ACCEL CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025