20 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Breast Localization Needles
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333003853·Hawkins™ II FlexStrand™ BLN 20ga x 5cm
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112458·BARRON VACUUM TREPHINE 6.0MM
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252050400·ceraMotion® Me Dentin C1, 40 g / dental ceramic...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197449328·Nasal Forceps by Blakesley Size 3
Ø5.0mm...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252050200·ceraMotion® Me Dentin C1, 20 g / dental ceramic...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252050900·ceraMotion® Me Dentin C1, 240 g / dental cerami...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197175098·Antrum trephine
180mm,...
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555287252050·ø7.2 Triple Lead Closed Polyaxial Screw Assembl...
Cranial 4Pi Immobilization
FDA 510(k)
FDA Class 2
·Radiology
Pencylcap
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 14, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 29, 2013
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 10, 2022
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 10, 2022
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 16, 2026
QUICKSET ACE GRATER HEAD 49MM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code HTO·December 6, 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