6 results
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7ms
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Sources: EU EUDAMED, US FDA
Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4" X 4" 12PL Y (6) TOWEL CLOTH HUCK BLUE (1) PK. STRIP STERI CLOSURE W X 4" (2) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER WITH RULER (1) RULER (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) SHEET o/. DRAPE 60" X 77" REINFORCED (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #10 CARBON STEEL (4) DRAPE UTILITY WITH TAPE (1) SYRINGE BULB 60CC (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F (1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) TUBE SUCTION CONNECT%'' X 12' (1) CAUTERY PENCIL PUSH BOTIOM HOLSTER 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
Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" 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
Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT~" X 12' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) BOWL UTIL TIY QUART 32oz (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER WITH RULER (2) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST SMS (10) SPONGE LAP PREWASH 18" X 18" XRD (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1) BLADE SURG. #15 CARBON STEEL (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE (10) GAUZE SPONGE 4" X 4" 16PLY (1) PK. STRIP STERI CLOSURE W' X 4" (1) NEEDLE SPINAL ANESTH 22G X 3Y2 (1) NEEDLE HYPODERMIC 22G X 1Y2 (1) IV PRIMARY ADD ADMINISTRAT SET (1) STOPCOCK 3WAY WSWIVEL MALE (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK 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
Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) BOWL UTILITY QUART 32oz. (1) COVER MAYO STAND REINFORCED (2) MARKER SKIN WITH RULER (1) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (1) TUBE SUCTION CONNECT X" X 12' (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1 0) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #1 0 CARBON STEEL (1) SYRINGE BULB 60cc (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F (1) SKIN STAPLE 35 WIDE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE (1 0) GAUZE SPONGE 4" X 4" 16 PLY (1) PK. STRIP STERI CLOSURE W X 4" 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
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO 21-2111-0300-09_KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA 21-2111-0300-09_OKA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA 21-2111-0300-09_OMI CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA 21-2111-0300-09_OSA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO 21-2111-0300-09_SAP CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO 21-2111-0300-09_TOK CADD_SOLIS_MODEL 2110_ENGLISH_1/EA 21-2111-0200-50JP CADD-Solis VIP CADD-SOLIS V4.2 LOAN FUK 21-2111-0402-09-FUK CADD-SOLIS V4.2 LOAN NAG 21-2111-0402-09-NAG CADD-SOLIS V4.2 LOAN OKA 21-2111-0402-09-OKA CADD-SOLIS V4.2 LOAN OSA 21-2111-0402-09-OSA CADD-SOLIS V4.2 LOAN SAI 21-2111-0402-09-SAI CADD-SOLIS V4.2 LOAN SAP 21-2111-0402-09-SAP CADD-SOLIS V4.2 LOAN TOKE 21-2111-0402-09-TOKE CADD-SOLIS V4.2 LOAN TOKW 21-2111-0402-09-TOKW CADD-SOLIS V4.2 LOAN YELLOW KYO 21-2112-0402-09-KYO CADD-SOLIS V4.2 LOAN YELLOW NAG 21-2112-0402-09-NAG CADD-SOLIS V4.2 LOAN YELLOW YOK ¿ 21-2112-0402-09-YOK CADD-SOLIS V4.2 LOAN YOK 21-2111-0402-09-YOK Number:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA 21-2111-0403-02 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA 21-2112-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA 21-2111-0300-00 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA ¿ 21-2111-0300-12 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA ¿ 21-2111-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA ¿ 21-2111-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA ¿ 21-2111-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA ¿ 21-2111-0300-07 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE 21-2111-0300-09JP PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA ¿ 21-2111-0300-232 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA ¿ 21-2111-0300-231 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA 21-2111-0300-244 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 Not PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA ¿ 21-2111-0300-17 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA ¿ 21-2111-0300-08 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA ¿ 21-2111-0300-14 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, DUTCH 1/EA 21-2112-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, GERMAN 1/EA 21-2112-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA 21-2112-0300-00 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA ¿ 21-2101-0200-12 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA ¿ 21-2101-0200-02 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA ¿ 21-2101-0200-03 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA ¿ 21-2101-02
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·May 14, 2025
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238, 21-2101-249, 21-2101-51, 21-2102-0200-02, 21-2102-249, 21-2102-51, 21-2111-0100-00, 21-2111-0100-50, 21-2111-0100-51, 21-2111-0200-02, 21-2111-0200-03, 21-2111-0200-06, 21-2111-0200-07, 21-2111-0200-08, 21-2111-0200-12, 21-2111-0200-14, 21-2111-0200-17, 21-2111-0200-232, 21-2111-0200-50, 21-2111-0300-00, 21-2111-0300-01, 21-2111-0300-02, 21-2111-0300-03, 21-2111-0300-06, 21-2111-0300-07, 21-2111-0300-08, 21-2111-0300-09, 21-2111-0300-12, 21-2111-0300-14, 21-2111-0300-17, 21-2111-0300-231, 21-2111-0300-232, 21-2111-0300-50, 21-2111-0400-01, 21-2111-0400-51, 21-2111-0401-02L, 21-2111-0401-03L, 21-2111-0401-06L, 21-2111-0401-07, 21-2111-0401-07L, 21-2111-0401-08L, 21-2111-0401-12L, 21-2111-0401-14L, 21-2111-0401-17L, 21-2111-0401-249, 21-2111-0401-51, 21-2111-0401-51L, 21-2111-0401-78, 21-2111-0402-02, 21-2111-0402-02L, 21-2111-0402-03L, 21-2111-0402-06L, 21-2111-0402-07L, 21-2111-0402-08, 21-2111-0402-08L, 21-2111-0402-09_LOAN, 21-2111-0402-09-FUK, 21-2111-0402-09JP, 21-2111-0402-09-KYO, 21-2111-0402-09-NAG, 21-2111-0402-09-OKA, 21-2111-0402-09-OSA, 21-2111-0402-09-SAP, 21-2111-0402-09-SEN, 21-2111-0402-09-TOKE, 21-2111-0402-09-TOKW, 21-2111-0402-09-YOK, 21-2111-0402-12L, 21-2111-0402-14L, 21-2111-0402-17L, 21-2111-0402-249, 21-2111-0402-51, 21-2111-0402-51L, 21-2111-0402-78, 21-2112-0100-50, 21-2112-0100-51, 21-2112-0200-02, 21-2112-0200-06, 21-2112-0300-00, 21-2112-0300-01, 21-2112-0300-02, 21-2112-0300-03, 21-2112-0300-06, 21-2112-0300-231, 21-2112-0300-50, 21-2112-0400-01, 21-2112-0400-51, 21-2112-0401-02L, 21-2112-0401-03L, 21-2112-0401-07L, 21-2112-0401-08L, 21-2112-0401-17L, 21-2112-0401-51, 21-2112-0401-51L, 21-2112-0401-78, 21-2112-0402-02, 21-2112-0402-02L, 21-2112-0402-03L, 21-2112-0402-06L, 21-2112-0402-07L, 21-2112-0402-08L, 21-2112-0402-09JP, 21-2112-0402-09-SAI, 21-2112-0402-09-SEN, 21-2112-0402-09-TOKE, 21-2112-0402-17L, 21-2112-0402-249, 21-2112-0402-51, 21-2112-0402-51L, 21-2120-0100-02, 21-2120-0100-03, 21-2120-0100-06, 21-2120-0100-232, 21-2120-0100-233, 21-2120-0100-50, 21-2120-0100-51, 21-2120-0100-95, 21-2120-0102-02, 21-2120-0102-03, 21-2120-0102-06, 21-2120-0102-07, 21-2120-0102-08, 21-2120-0102-12, 21-2120-0102-13, 21-2120-0102-14, 21-2120-0102-15, 21-2120-0102-17, 21-2120-0102-247, 21-2120-0102-249, 21-2120-0102-51, 21-2120-0102-78, 21-2120-0102-92, 21-2120-0102-98, 21-2120-0103-01, 21-2120-0103-02, 21-2120-0103-03, 21-2120-0103-06, 21-2120-0103-07, 21-2120-0103-08, 21-2120-0103-14, 21-2120-0103-15, 21-2120-0103-17, 21-2120-0103-249, 21-2120-0103-51, 21-2120-0103-78, 21-2120-0104-01, 21-2120-0105-00, 21-2120-0105-01, 21-2120-0105-02L, 21-2120-0105-03L, 21-2120-0105-06L, 21-2120-0105-07L, 21-2120-0105-08L, 21-2120-0105-12L, 21-2120-0105-13L, 21-2120-0105-14L, 21-2120-0105-15L, 21-2120-0105-17L, 21-2120-0105-231, 21-2120-0105-50, 21-2120-0105-50L, 21-2125-0104-01, 21-2125-0105-07L, 21-2125-0105-08L, 21-2125-0105-50L, 21-2127-0104-01, 21-2127-0105-01, 21-2127-0105-02L, 21-2127-0105-03L, 21-2127-0105-06L, 21-2127-0105-08L, 21-2127-0105-50L, 22-4095-0203-51, 22-4095-0204-25, 22-4095-0205-25.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·November 6, 2024