B Braun Medical Industries Sdn Bhd

FDA Filings

This page includes the latest FDA filings for B Braun Medical Industries Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9612086
• FEI Number: 3002806575
• Name: REBECCA A. STOLARICK
• Owner & Operator: B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
• Contact Address: BAYAN LEPAS FREE TRADE ZONE --; PENANG MY-NOTA -- MY
• US Agent:
  • REBECCA A. STOLARICK
  • B. BRAUN MEDICAL, INC.
  • 610 5962536
  • 610 2664962
  • REBECCA.STOLARICK@BBRAUNUSA.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 901 MARCON BLVD. ; ALLENTOWN, PA 18109 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K182870 | FOZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Introcan Safety 3	2019-04-22
PMN K173803 | FMI REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Omnican fine	2018-09-07
PMN K932569 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Pencan	2017-12-05
PMN K932569 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Pencan	2017-12-05
PMN K170897 | FPA REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Surecan Safety II	2017-11-29
PMN K163358 | FOZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Introcan Safety 3	2017-05-02
PMN K152050 | FMI REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Pencylcap	2016-04-22
PMN K853014 | LCJ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Winged Infusion Set	2013-12-03
PMN K853014 | LCJ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Infusion Set	2013-12-03
PMN K131842 | FMI REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Sterican	2013-09-03
PMN K081905 | MEB REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	EasyPump	2013-08-08
LXH REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Orthopedic Instrument	2012-11-28
LRW REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Scissors	2012-11-28
KCH REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Hook	2012-11-28
KAL REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Retractor	2012-11-28
KAE REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Forceps	2012-11-28
HYA REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Forceps	2012-11-28
HXK REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Holder	2012-11-28
HXD REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Clamp	2012-11-28
HWB REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Extractor	2012-11-28
HTR REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Rasp	2012-11-28
HTD REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Forceps	2012-11-28
HRR REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Scissors	2012-11-28
HRQ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Hemostat	2012-11-28
HNR REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Forceps	2012-11-28
HNF REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Scissors	2012-11-28
HDL REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Retractor	2012-11-28
HDF REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Speculum	2012-11-28
GES REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Blade	2012-11-28
GEN REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Forceps	2012-11-28
GEG REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Elevator	2012-11-28
GEF REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Applier	2012-11-28
GDZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Handle	2012-11-28
GDX REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Scalpel	2012-11-28
GDJ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Clamp	2012-11-28
GDI REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Dissector	2012-11-28
GDG REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Hook	2012-11-28
GDF REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Guide	2012-11-28
GAF REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Spatula	2012-11-28
GAD REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Retractor	2012-11-28
FZS REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Curette	2012-11-28
FMA REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Tongue Depressor	2012-11-28
FHQ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Holder	2012-11-28
FGN REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Retractor	2012-11-28
FFO REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Retractor	2012-11-28
FFN REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Clamp	2012-11-28
EMN REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Scaler	2012-11-28
EMG REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Forceps	2012-11-28
EMF REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Knife	2012-11-28
EMD REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Hemostat	2012-11-28
EJB REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Handle	2012-11-28
EIG REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Retractor	2012-11-28
EFL REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Forceps	2012-11-28
DWS REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Surgical Instrument	2012-11-28
PMN K111236 | FOZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Introcan Safety 3	2012-05-07
PMN K112515 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Pencan and Spinocan Spinal Introducer Needles	2012-05-02
PMN K813236 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Epican	2011-11-15
PMN K033575 | FMI REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	One Click Needle	2009-11-05
PMN K813186 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perifix	2008-12-03
PMN K813186 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perifix Tuohy	2008-12-03
PMN K813186 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perican Tuohy	2008-12-03
PMN K813186 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Non-winged Tuohy	2008-12-03
PMN K813179 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perifix	2008-12-03
PMN K813179 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perifix Hustead	2008-12-03
PMN K813179 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perican	2008-12-03
PMN K813179 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perican Hustead	2008-12-03
PMN K813179 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Accu Bloc	2008-12-03
PMN K072247 | FMI REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Sterican	2007-11-20
PMN K962696 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perifix	2007-11-07
PMN K962696 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Perifix Pediatric	2007-11-07
PMN K932400 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Espocan	2007-11-07
PMN K932400 | CAZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Espocan Tuohy	2007-11-07
PMN K932400 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Espocan	2007-11-07
PMN K932400 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Espocan Tuohy	2007-11-07
PMN K820047 | BSP REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Spinocan	2007-11-07
PMN K021094 | DYB REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Introcan Safety	2007-11-07
PMN K020785 | FOZ REBECCA A. STOLARICK [B. BRAUN MEDICAL INDUSTRIES SDN. BHD.]	Introcan Safety	2007-11-07

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092418080	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	106 PKG
2020092418080	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	106 PKG
2020092418080	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	106 PKG
2020092418080	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	106 PKG
2020092418080	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT MEDICAL PRODUCTS 106 PACKAGES (12023 CARTONS) INV NO 787171235 787172254 787172169 787171537	106 PKG
2020091730927	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	52 PKG
2020091730927	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	52 PKG
2020091730927	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT MEDICAL PRODUCTS 52 PACKAGES (5297 CARTONS) INV NO 787162068, 787162057 787162071 787162055 .	52 PKG
2020091418850	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	133 PKG
2020091418850	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	133 PKG
2020091418850	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	133 PKG
2020091418850	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	133 PKG
2020091418850	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	133 PKG
2020091418850	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT MEDICAL PRODUCTS 133 PACKAGES (16,480 CARTONS) INV NO 787154437 787154441 787154442 787155416,787155417,787155558,	133 PKG
2020091433617	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	EMPTY PLASTIC CORE . .	1 PKG
2020090421408	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	39 PKG
2020090421408	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT MEDICAL PRODUCTS 39 PACKAGES ( 5126 CARTONS) INV NO 787109153 787109154 SD.13067594 / INV NO.787109153 CONTAINER CONTAIN	39 PKG
2020090210645	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	78 PKG
2020090210645	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	78 PKG
2020090210645	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	78 PKG
2020090210645	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT MEDICAL PRODUCTS 78 PACKAGES (8329 CARTONS) INV NO 787095277 787095076 787095259 787095261	78 PKG
2020090113720	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	78 PKG
2020090113720	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	78 PKG
2020090113720	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	78 PKG
2020090113720	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT MEDICAL PRODUCTS 78 PACKAGES (8329 CARTONS) INV NO 787095277 787095076 787095259 787095261	78 PKG
2020082024486	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	77 PKG
2020082024486	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	77 PKG
2020082024486	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT	77 PKG
2020082024486	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCT MEDICAL PRODUCTS 77 PACKAGES (8772 CARTONS) INV NO 787086512 787086513 787086726 787086787, 787086788	77 PKG