27 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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T2 GREATER TROCHANTER NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Bur PM2-70 80K FC Ø2.0x80 St
FDA UDI
Bien-Air Surgery SA·17630055519822·
ARGESOL 600 STRIP
FDA UDI
ARGEN CORPORATION, THE·D818101438·Gold based noble metal
Oticon
FDA UDI
Oticon A/S·05707131164209·K14, RITE SGR
SEMIAL 10°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844000861·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...
AIM™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868003578·
NITANIUM® SUPER ELASTIC ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707060176·.020 UPPER NITANIUM® SUPER ELASTIC OVAL ARCH FO...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383501149·Gutta Percha Points is used to root canal filin...
ENDOSKELETON® TCS
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00191375032052·Rigid Container System Tray, Lower
UniTip Catheter
FDA UDI
Unisensor AG·07640172971239·
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CONTROL BAR ASSEMBLY
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·May 3, 2013
DXTEND GLENOSPHERE ECC D42MM
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code HSD·September 19, 2014
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·May 2, 2011
Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;
FDA Recall
Terminated
·Cardinal Health·Product code LRO·June 27, 2003
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
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
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025