SER - BEUDAMED

Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments

FDA Enforcement

Class II ·Terminated·Carl Zeiss Meditec AG·October 11, 2017

Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

FDA Enforcement

Class II ·Terminated·Johnson & Johnson Surgical Vision Inc·November 21, 2018

Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

FDA Enforcement

Class II ·Terminated·MicroAire Surgical Instruments, LLC·June 8, 2016

Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

FDA Enforcement

Class II ·Terminated·Zimmer Biomet, Inc.·May 17, 2017

1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]

FDA Enforcement

Class II ·Ongoing·Daavlin Distributing Company·May 18, 2022

4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

FDA Enforcement

Class II ·Ongoing·Daavlin Distributing Company·May 18, 2022

Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.

FDA Enforcement

Class II ·Terminated·Toshiba American Medical Systems Inc·September 6, 2017

Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 2-8-218 ASSY HOOKUP OLY 2K 2-8-236 ASSY, HOOKUP FUJINON 2K 2-8-244 ASSY, HOOKUP, STORZ 2K 2-8-245 ASSY, HOOK-UP, STORZ 2K 2-8-246 ASSY, HKUP, PENTAX-2K 2-8-260 ASSY, HOOK-UP WOLF 2-K 2-8-280 ASSY HOOKUP 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 2-8-330 ASSY, HOOK-UP, PENTAX-3K 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 2-8-336 ASSY,HKUP FUJI 70 BRONC 2-8-338 ASSY, HU, FUJI BRONCH U/S 2-8-421 ASSY, HOOKUP, FUJIFILM 2-8-428 ASSY, ED-580XX 2-8-431 ASSY, HOOKUP, PENTAX 2-8-432 ASSY, HOOK-UP, PENTAX 2-8-460 HOOKUP, ASSY WOLF 4K 2-8-511 ASSY, HOOK-UP, OLY 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 2-8-522 ASSY, FUJINON 4K-JET 2-8-523 ASSY, HKUP, FUJI 4K SER 5 2-8-526 ASSY, HOOKUP FUJI 4K+JET 2-8-527 ASSY, FUJI 700 NO FWJ 2-8-528 HOOK, EI-580BT 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 2-8-537 ASSY, HKUP, PTX90 4K+JET 2-8-539 HOOK, PTX I20 FWJ 2-8-540 ASSY-HOOK-UP,STORZ,5K 2-8-611 ASSY, HOOK-UP, OLY 2-8-612 ASSY, HOOKUP, PENTAX 2-8-614 ASM HU OLY TGF-UC180J 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 2-8-625 ASSY, HOOKUP, EG-580UT 2-8-626 ASSY, HOOKUP, EG-580UR 2-8-627 ASSY, HKUP, FUJI 700 SER 2-8-634 ASSY, HOOKUP PENTAX DUAL 2-8-639 HOOK, EG3X-J10 2-8-640 ASSY,HOOK-UP STORZ 6K 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 2-8-718 ASSY, HOOKUP, OLY 160/180 2-8-740 ASSY, HOOK-UP, STORZ 2-8-811 ASSY HKUP OLY-ECHO+LIFT 2-8-901 KIT TEE/TOE/RUS HU ADV+ 5-8-010 ASSY, HOOKUP DBL LT 5-8-030 ASSY, HOOKUP 5-8-040 ASSY HOOKUP STORZ 0K DBL 5-8-050 ASSY, HOOKUP, DILATOR 5-8-112 HOOKUP 2-SCOPE 1-K 5-8-190 HOOK DBL, IS, ION 5-8-210 ASSY, HOOKUP 5-8-245 HOOKUP KARLSTORZ-2K 2-8-001HAN HU ZERO CHANNEL NO LT 2-8-002HAN ADVANTAGE TEST BLOCK 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 2-8-160HAN ASSY, ADV HOOKUP, WOLF 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K 2-8-218HAN ASSY HOOKUP OLY 2K 2-8-245HAN ASSY, HOOKUP, STORZ-2K 2-8-330HAN ASSY, HOOK-UP, PENTAX-3K 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 2-8-335HAN ASSY,HOOKUP,OLYMPUS 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 2-8-421HAN ASSY, HOOKUP, FUJINON 2-8-428CAS HOOK, CAS, ED-580XX 2-8-428HAN HOOK, HAN, ED-580XX 2-8-431CAS ASSY, CASSETTE, PENTAX 2-8-431HAN ASSY, HOOK-UP, PENTAX 2-8-511HAN ASSY, HOOK-UP, OLY 2-8-526HAN ASSY, HOOKUP FUJI 4K+JET 2-8-536HAN HOOKUP,PENTAX,70ULT, 5K 2-8-537CAS ASSY,CASS,PTX 90 4K+JET 2-8-537HAN ASSY HKUP,PTX90 4K+JET 2-8-611HAN ASSY, HOOK-UP, OLY 2-8-626CAS ASSY, CASS, FUJINON 580UR 2-8-627HAN ASSY, HAN, FUJI 700 SER 2-8-634CAS ASSY,CASS PENTAX DUAL CH 2-8-634HAN ASSY,HOOKUP PENTAX DUAL 2-8-640HAN ASSY, HOOK-UP STORZ 6K 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K 2-8-718HAN ASSY,HOOK-UP, OLY 160/180 2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT 2-8-902H HU BLOCK ULTRASOUND PROBE 5-8-030HAN ASSY, HOOKUP 5-8-050HAN ASSY,HOOKUP, DILATOR 5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K 5-8-244HAN ASSY, HKUP 2K DBL

FDA Enforcement

Class II ·Ongoing·Steris Corporation·January 3, 2024

Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr Ser Lgth 210MM; (8) REF BJ527R, Wiener Hyst Forceps Grooves 240MM; (9) REF BJ530R, Heaney Hysterectomy Forceps STR 225MM; (10) REF BJ531R, Heaney Hysterectomy Forceps CVD200MM; (11) REF BJ532R, Heaney Hysterectomy Forceps CVD215MM; (12) REF BJ534R, Hysterectomy For.Gwilliamsstr.205MM; (13) REF BJ550R, Wertheim Parametrium Clamp STR 250MM; (14) REF BJ551R, Wertheim Parametrium Clamp CVD245MM; (15) REF BJ552R, Wertheim Parametrium Clamp CVD240MM; (16) REF BJ553R, Wertheim Parametrium Clamphvy-CVD220MM; (17) REF MD591, Heany Ballentine Hyst Fcps STR.215MM; and (18) REF MD592, Heany Ballentine Hyst Fcps CVD.215MM.

FDA Enforcement

Class II ·Ongoing·Aesculap Inc·March 19, 2025

ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

FDA Enforcement

Class II ·Terminated·Brainlab AG·March 21, 2018

Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M

FDA Enforcement

Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024

Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

FDA Enforcement

Class II ·Ongoing·The See Clear Company·March 15, 2017

Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).

FDA Enforcement

Class II ·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024

SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.

FDA Enforcement

Class II ·Terminated·Sr Instruments Inc·April 24, 2013