21 results
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19ms
·
Sources: EU EUDAMED, US FDA
IPGTFL-02
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALIGNMENT GUIDE LOCKING BOLT PROXIMAL HUMERAL PLATE
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665006124·
R1 shock-proof manometer white, 1 tube, without cuff
FDA UDI
Rudolf Riester GmbH·04045396159877·Aneroid sphygmomanometers for non invasive meas...
ELMED
FDA UDI
ELMED INCORPORATED·00842180172524·EMBED SPECULUM RETRACTOR - 3 BLADES FOR GALL BL...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522511000·
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORN74102511001·Mini-Mono-Bracket Roth 'N' .022" max. 2 right
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORO74002511001·Mini-Mono-Bracket Roth 'N' .022" max. 2 left
IPL HAIR REMOVAL DEVICE CT05
FDA Adverse Event
Injury
·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·February 19, 2026
HAND-HELD HAIR REMOVAL DEVICE
FDA Adverse Event
Injury
·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·March 9, 2026
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555287251100·ø7.2 Triple Lead Reduction Screw Assembly, 100mm
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
FDA 510(k)
FDA Class 2
·General Hospital
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OZO·February 14, 2022
UNKNOWN M2A-38 HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 14, 2014
2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JEY·September 13, 2011
ELLIPS FX PHACO HANDPIECE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQC·July 29, 2013
MEDTRONIC ICD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·August 23, 2023
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·August 23, 2023
Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code GAA·September 1, 2009
Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code GDM·September 1, 2009