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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Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDER NAIL
FDA UDI
Smith & Nephew, Inc.·03596010104427·3.5MM DIAMETER NAIL 3.5MMX30CM
...
Viper Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235308·
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551077634·Dissector, sharp, long, 17 cm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021388·FPS 3.5mm x 30mm Locking Screw
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044201147·Sterile 30 mL Freestanding Centrifuge Tubes wit...
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112196·Pinnacle .022 MC LR5 HK G/O -17T 2A 0O (10PK)
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010247·Pinnacle .022 MC LR5 HK G/O -17T 2A 0O (10PK)
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114107·Votion .022 MC LR5 HK G/O -17T 2A 0O (10PK)
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008411·Votion .022 MC LR5 HK G/O -17T 2A 0O (10PK)
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075800·FPS 3.5 x 30mm Locking Screw Sterile Qty 2
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026