26 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
FDA 510(k)
FDA Class 2
·Radiology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551057544·Cotton Applicator, standard model, 13 cm
AGXO
FDA UDI
Oticon A/S·05707131282668·H110V2, BTE 13 WL 85 CNB AGXO
AGC Tradition Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304001770·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040648·PrimaLIF LLIF 7mm x 18mm Lordotic Trial
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613043810·Orange AutoClavable Surgical Identification Tap...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306830839·Instrument ID Tape, Orange, Roll 6.35mm x 762cm
ELMED
FDA UDI
ELMED INCORPORATED·00842180162013·BURR (16MM
Symmetry Hudson
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482000335·Symmetry® Burr; Hudson; 16 mm
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100011·BARRAQUER WIRE SPECULUM LARGE WITH TABS
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521510070·
NA
FDA UDI
aap Implantate AG·04042409192227·Cortical Screw 1.5, self-tapping, L 7
MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU02 SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
aap Implantate AG·04042409192425·Cortical Screw 1.5, self-tapping, L 7
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·June 6, 2013
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
UNSPECIFIED SYMBIQ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·August 28, 2008
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·September 12, 2016
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·December 25, 2019