19 results · 21ms · Sources: EU EUDAMED, 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