19 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
FDA Enforcement
Class II
·Ongoing·Surgical Theater Inc·November 5, 2025
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
FDA Enforcement
Class II
·Ongoing·Philips North America·December 17, 2025
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code 67285; g) STERILE 5 1/2" NAIL NIPPER (32195), Product Code 67365; h) STERILE 4 1/4" CUTICLE NIPPER (32908), Product Code 67420; i) STERILE ENGLISH ANVIL NAIL SPLITTER-5", Product Code 67595; j) STERILE UNIVERSAL RING CUTTER(FS02470), Product Code 67780; k) STERILE FINGER NAIL CLIPPER, Product Code 589784ST; l) BILLEAU EAR LOOP 4MM 6" LARGE, Product Code BEL46ST; m) PROBE WITH EYE, Product Code DYND04011; n) STERILE 9" MAYO SCISSOR (ST150), Product Code I67350; o) STRL ROCHESTER OCHSNER SATIN 7 1/4", Product Code I67695; p) CMP* NAIL NIPPER ANGLED 4.5, Product Code I67980; q) STERILE BILLEAU EAR LOOP 3MM, Product Code I67995; r) ST. ALLIGATOR FORCEP, POINTED, MICRO P/S, Product Code I68020; s) MOSQUITO HEMOSTAT FINE TIP, Product Code I68190; t) STERILE VAS DEFERENS CLAMP (VDC100S), Product Code I68200; u) LILLIE EAR HOOK, 7" STERILE (P/S), Product Code I68305; v) ST FOX DERMAL CURE, 4MM, 5 1/2 (32922), Product Code I68360; w) STERILE SKIN HOOK - SHARP (SH25754), Product Code I68415; x) ST. EYE LID SPECULUM WIRE ADULT (ES500P), Product Code I68460; y) STERILE NAIL RASP DOUBLE ENDED (NR100), Product Code I68500; z) ST. SCLERAL DEPRESSOR 5.5" (SD500), Product Code I68515; aa) STERILE NAIL SPLITTING FORCEP 4" (NS400), Product Code I68600; bb) STERILE 12" PROBE W/ EYE, Product Code I68840; cc) COMEDONE EXTRACTOR, STERILE (P/S), Product Code I86540; dd) STERILE SPATULA & PACKER, Product Code I86695; ee) STERILE - PHLBCTMY HOOK CRCHT STYL 6, Product Code I86875; ff) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code P-67285 MEDLINE PROBE WITH EYE, Product Code DYND04011
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Enforcement
Class II
·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023
CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
FDA Enforcement
Class II
·Ongoing·Carefusion 2200 Inc·November 23, 2022
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
FDA Enforcement
Class II
·Ongoing·Treace Medical Concepts, Inc.·September 4, 2024
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
FDA Enforcement
Class II
·Ongoing·Carefusion 2200 Inc·November 23, 2022
CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
FDA Enforcement
Class II
·Ongoing·Carefusion 2200 Inc·November 23, 2022
BD Pyxis Mini Main REF: 349 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedStation ES REF: 323 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedStation 4000 REF: 303 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·June 24, 2026
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026