17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120234101·Carbide - Surgical instrumens, bone cutter
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154184249·Bone Screws, Cross-Pin
NA
FDA UDI
STERILMED, INC.·10888551019903·SAW BLADE GRAFT HARVESTING W/20MM DEPTH STOP 10...
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962106266·ø1.0mm K-WIRE, 2 3/4", SINGLE TOCAR (ROUND END)...
AT HOME DRUG TEST, MODEL 9064
FDA 510(k)
FDA Unclassified
·Unknown
CONCENTRIC RETRIEVER, MODEL 90030
FDA 510(k)
FDA Class 2
·Cardiovascular
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
MITEK RIGIDFIX BONE TENDON BONE 2.7MM CROSS PIN KIT
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MAI·March 27, 2013
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011
ACP 3 LVL SPIKELESS PLATE 56MM
FDA Adverse Event
Injury
·ABBOTT SPINE·Product code JDN·April 2, 2008
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
DISPOSABLE MICROFORCEPS: ILM.(23 GAUGE / 0.6 MM)
FDA Adverse Event
Malfunction
·D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.·Product code HNR·October 19, 2023
DISPOSABLE MICROFORCEPS: ILM.(23 GAUGE / 0.6 MM)
FDA Adverse Event
Malfunction
·D.O.R.C. DUTCH OPTHALMIC RESEARCH CENTER INT.·Product code HNR·January 20, 2026
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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