22 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 15, 2012
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system
FDA Enforcement
Class I
·Terminated·Asensus Surgical Inc·November 8, 2023
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class I
·Ongoing·Alcon Research LLC·December 31, 2025
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
FDA Enforcement
Class I
·Ongoing·MEDTECH SAS·November 3, 2021
NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) Pr. SURGICAL GLOVES 7 Y2 (2) Pr. SURGICAL GLOVES 8 (2) EAR ULCER SYRINGE 2oz LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) SHEET MINOR LAP 102" X 121" X 78" (1) SAFETY SCALPEL #10 (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (4) CLOTH HUCK TOWELS BLUE (1) PENCIL CAUTERY ROCKER SWITCH (2) LEGGINS W/7'' CUFF 30" X 42" (1) DRAPE% ECONOMY 53" X 77" LIF (1) Pk. SURGICAL STRIP 'X" X 6" (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (2) ROUND WASH BASIN 6QT (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE (2) Pr. SURGICAL GLOVES 7 (1) SKIN MARKER WITH RULER LIF (1) Pk. STERI STRIP CLOSURE %"X 4" LIF (1) TUBE SUCTION CONNECT. 'X" X 12' LIF (1) SAFETY SCALPEL #15 (1) SAFETY SCALPEL #11L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
FDA Enforcement
Class I
·Ongoing·Ethicon Endo-Surgery Inc·May 28, 2025
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
FDA Enforcement
Class I
·Terminated·Stryker Howmedica Osteonics Corp.·April 24, 2013
LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4" L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (10) LAP SPONGES PREWASH 18" X 18" XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc·February 20, 2013
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Il l LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4" L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (1 0) LAP SPONGES PREWASH 18" X 18" XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) CUP MEDICINE 2oz UF (2) TUBE SUCTION CONNECT v.'' X 12' UF (2) SKIN MARKER INK WITH 8 LABEL (20) GAUZE SPONGE 4" X 4" 16ply XRD UF (5) SPONGE LAP PREWASH 18"X 18" XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF (1) YANKAUER SUCT. TUBE W/0 VENT LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) POLISHER CAUTERY TIP LIF (2) PENCIL CAUTERY HAND SWITCHING LIF (1) DRAPE T LAPAROTOMY 102" X 78" X 121" STD SMS LIF (1) GOWN SURG REINFORCED LARGE TOWEL WRAP (2) BLADE SURG #15 CARBON STEEL (1) PK.STRIP SURGICAL %" X 6" COTTON (1) PK.STRIP SURGICAL Y4" X 6" COTTON (10) GAUZE SPONGE 4" X 4" 16ply (1) NEEDLE HYPODERMIC 20G X 1 % (1) BASIN WASH ROUND 6qt (4) SHEET DRAPE 42" X 57" SMS LIF (2) DERMABOND HV TOPICAL SKIN ADH (1) BOWL UTILITY 32oz. (2) SYRINGE EAR/ULCER 2oz LIF (2) BLADE EXTENDED ELECTRODE (2) SOLUTION SURGICAL DURAPREP 26mL UF (1) ELECTRODE NEEDLE 1in W/TIP PROTECTOR (1) STRIP SURGICAL 'I"X 6" (2) GOWN XL SMS IMPERV. REINFORCED UF (1) CORD BIPOLAR FIRCEPS (4) TOWEL CLOTH HUCK (WHITE) (2) DRESSING OPSITE POST PO 2%" x 2" (2) POUCH INSTRUMENT 7 X 11 (1) MAYO TRAY LARGE (1) MAYO STAND COVER REINFORCED UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1) INCISION DRAPE 23" x 17" (1) INSTRUMENT POUCH (2) CAUTERY TIP POLISHER LIF (1) CAUTERY PENCIL HANDSWITCHING LIF (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF (2) LITE GLOVES LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF (1) Pk SURGICAL STRIP W'X 6" (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL (5) DRAPE % ECONOMY 53" X 77" LIF (2) TABLE COVER HD 77" X 110" L!F (1) MAYO TRAY LARGE (1) UTILITY BOWL 16 oz LIF (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL (1) J VAC RESERVOIR 300 mL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
FDA Enforcement
Class I
·Terminated·Vycor Medical, Inc.·January 23, 2013
NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W' X I 2' LIF (I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF (I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23" X 1 7" LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF (2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77" X 110" HD FULL L/F (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF ( I ) DRAPE T LAPAROTOMY 102" X 78" X 1 21" STD SMS (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE 'l'4 ECONOMY 53" X 77" LIF (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT 110" X 77" (1 ) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGES 4" X 4" 12PLY (6) TOWELS CLOTH HUCK C BLUE (1 ) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (6) 3/4 SHEET DRAPE REINFORCED LIF (2) STOCKINETTE 9" X 48" LIF (1) SPLIT SHEET BILATERAL 84" X 80" LIF (3) DRAPE SHEET 41" X 58" SMS LIF (4) Pr. GLOVES SURGEON #7 BIOGEL OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- (1) PLASTIC RULER 12" LONG (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F (1) Pk. PEANUT SPONGE DISSECTOR ST. (2) UTILITY BOWL 32 oz. LIF (1) SKIN MARKER WITH RULER LIF (2) UTILITY BOWL 16 oz. UF (3) BULB SYRINGE 60cc UF (1) MAYO TRAY SMALL L/F (2) YANKAUER SUCT. TUBE WITHOUT VENT UF (1) TRAY ORGANIZER FULL DEEP LIF (5) SAPHENOUS VEIN CANNULA LIF (40) LAP SPONGES PRE-WASH XRD UF (2) ELASTIC BANDAGE 6" X 5 yds. UF (2) SUTURE BAG FLORAL (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF (1) BLADE SHARP ALL ARROUND 69 (1) SURGICAL BLADE# 11 CARBON STEEL (4) LITE GLOVES UF (2) SURGICAL BLADE# 15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF (2) POUCH INSTRUMENT (2) SURGICAL BLADE# 10 CARBON STEEL (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF (2) CAUTERY PENCIL ROCKER SWITCH LIF (2) POLISHER CAUTERY TIP UF (1) LABEL SET, HEPARINE,SALINE (2) ELASTIC BANDAGE 4" X 5 yds. LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF (2) COTION GLOVE HEAVY DUTY (1) AORTIC MONITORING PRESS SET 5.0 (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF (2) NEEDLE HYPODERMIC 22G X 1 % LIF (1) BLADE 6.1 X 32.3 X 1.0MM (1) SQUARE TWO PIECE 500cc GRADUATE (2) CONNECTOR REDUCER (1) NEEDLE BLADE/KNIFE 3.0MM EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P CLOSURE 'h" X 4" ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK (2) SYRINGE I ML WITHOUT NEEDLE LILOCK (I) CAUTERY TIP POLISHER (I) SHEET ENT SPLIT 110" X 77" SMS ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V (2) LITE GLOVE (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT W' X 1 2' (I) EAR ULCER SYRINGE 2oz (I) TABLE COYER REINFORCED 50" X 90" ( I) UTILITY BOWL 16oz (4) APPLICATOR COTTON 6" WOOD (2) STRJPS TAPE 24" X 4" ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK ( I ) MAYOTRAY SMALL ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 ( I ) TI ME OUT BEACON NON WOVEN (I) BLADE M IN IATURE CARBON STEEL (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD (I) SK I N MARKER INK W/8 LABEL (2) NEEDLE HYPODERM I C 27G X I W' ONE PACK WET SK IN W ITH CONTENTS: ( I ) WRAPPER SMS 30" X 30" (2) COTTON TIP APPLICATOR 6" WOOD (2) GLOVE MED FREETOUCH VYNIL P/F (6) SPONGE W ING SMALL (4) TOWELS ABSORBENT 1 5" X 20" (3) TIP ABSORB. APPLICATOR STI CK SPONGE ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE (I) PVP SCRUB SOLUTION 4oz. BOTTLE (I) TRAY 3/COMPARTMENT Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014