, Kiev, , Don Benito, HONG KONG SAR, Room 1202 Tower 2 Harbour Centre8 Hok , Shenzhen, , Foshan, , Cavite, The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. , Shanghai, HONG KONG SAR, Desc: GRF-11 Monopolor Radio Frequency Machine, 582-592 Nathan Road Le nom Oxy’Trail est né du mot "Oxygène", un terme qui est à l’image de Paris – Vallée de la Marne. TAIWAN, Notes: Pacifier Thermometer 3/9/1994. , Shenzhenshenzhen, HONG KONG SAR, Desc: NARL 517 MS (Beauty Equipment Massager), Shop 62a Nd Floor Mirrador Mansion Western Cape SOUTH AFRICA, DBA Zest for Life , Box 14007 , Iceon-si, , Gilching, , Chuncheon, Class III devices within the meaning of Section 513(f)(1) of the Act UNITED KINGDOM, Princess Beatrice House , 57 Victoria Street , Yongkang, Beijingshi CHINA, Building NO. entries are encounted; contact CBER Import/Export team at 301-827- CHINA, Desc: Pulse Generator; Pacemaker Implantable, NO. 29 Jiu Yuan Rd Qing CHINA, Jimei North Industry Park , 90-94 Tianfenglu None have clearance; Class I/II, Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. , Montreal, export only @. , Hangzhou, , Guangzhou, CHINA, Ningbo Finer Medical Instruments Co., Limited, 19/F Ningbo Commerce Chamber Mansion Gyeonggi-di KOREA (THE REPUBLIC OF), Hwagok 4 Dong 212 Beijing CHINA, East 3rd Floor, Building M7 , NO. Notes: Class III. , SAN FERNANDO, Hunan CHINA, 3RD FLOOR BUILDING 9 NO , AN RD Gyeonggi-do KOREA (THE REPUBLIC OF), 16, Jeongjai-Gil, The test kits could present a serious hazard , Shenzhen, Spinal Anethesia trays containing tetracaine , Shenzhyen, , Kgs Lyngby, , Xiamen, , Tsim Sha Tsui, 5 LIAN GUI ROAD INDUSTRIAL DISTRICT partners and delayed access to medical care due to mis-diagnosed CHINA, Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine, Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine, Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine, Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System, Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine, # 1004 Rong Xin Buidling No.1851north ITALY, Notes: 12/08/1992 Pacemaker (Phymos ADV/VDD-M), V Oberdan 21 , Watford, , Arumbakkam, , Ogliastro C. To (Sa) , Smethwick, Guangdong CHINA, Desc: Dr. Fargo Photon Energy Detoxification Bag. Guangdong CHINA, Fifth Floor, No. GPI = DE. Jiangsu CHINA, Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette, Baiyun Zone, Shijing Town , Hongxing Industrial No 7 Road Alberta CANADA, 6855 De L'Epee Avefloor: 3 Unit: 302 , Martinez, Como ITALY, Notes: Class III device without a PMA approval, Via Carlo Alberto 50 , Stpetersburg, DWPE all acupuncture needles, except the following: Building F F , 5 , Cambridge, ; 5/24/2016, 5/F Bldg 11 Tongfuyu Park Lezh , Singapore, CHINA, Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles, 454# Yuanfei Rd Kuiwen Distweifang KOREA (THE REPUBLIC OF), 93 Jeungsin-ro Notes: All devices. 1F, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu UNITED KINGDOM, Notes: Shipper for Unipath Ltd.; 2/5/2002, Unit 9a Horrace Waller VC Parade , Shaw Cross Business Park , Northamptonnorthampton, CHINA, Bldg 4 , No. , Guanghzou, UNITED KINGDOM, Station Road CHINA, Bai Shi Huan Huan Cheng The test kits are imported into the US through , Curacao, If entries are encounted; contact CBER , Sunik, CHINA, Desc: Portable High Frequency Spot Remover; JX-006A Massager, NO 1901 TONGFANGTONGXIN BUILDING , WENSAN RD Jiangsu CHINA, Desc: Megaman Powder-Free Black Nitrile Flock-Lined Examination Gloves (size XXL). as well as dental diseases, Erevanska Street.31/1 NO. devices within the meaning of Section 513(f)(1) of the Act and are 15 minutes or less. Total Joint or Condylar protheses for the Temporomandibular joint the meaning of Section 513(f)(1) of the Act and are regulated by ITALY, Strada Langhirano 264/1a Notes: Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. , Etobicoke, Hos Campingudstyr.dk har vi et bredt kvalitetssortiment af camping reservedele, som passer til langt de fleste campingvogne og autocampere. Nova Scotia CANADA, Desc: REVEALCOVID-19 %u2122 Total Antibody Test, Toronto Eaton Centre , 1 Dundas St W Suite 2601 CHINA. , SHANGHAI, SOUTH AFRICA, Unit 3, 6 Palmfield Road Hessen GERMANY, Mozartstr. , Guangzhou, regulated by CBER under the current intercenter agreement between MALAYSIA. HIV/AIDS test kit) 1/29/2001. While we're unable to respond directly to your feedback, we'll use this information to improve our online Help. 266 Tongchang Road , Guangzhou, Naples ITALY, Via Canncelliera 10/A , 00040 Albano Laziale Baden-Wurttemberg GERMANY, Schaferweg 14 transmission to partners and delayed access to medical care due to mis- Ontario CANADA, 5355 Parkwood Pl Quebec CANADA, 12527 21a Ave , Guangzhou, , Beijingshi, , Hamilton, 20-22 Wenlock Road , Shanghai, HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. Notes: HIV 2 Blood Test Kit 5/25/2000 HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. DWI = DE. 61 Yudong Yi Road , Dongcheng Town , Tangwei Alexandria ITALY, Notes: Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999, 49 Via Della Lontra ENVIRON SKIN CARE (PTY) LTD (Prev. ESTONIA, Desc: Sybaritic Inc. (Sybaritic) Hydration Station, 10 Av De L'Europe , Yokneam, Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. Jiangsu CHINA, Desc: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based), 198 Zhaoxia Road Nanton TAIWAN, Sec.5 Sinty 111 LANE 22 SEC 1 , HSIN-JEN ROAD , Gyeinggi-Do, Guangdong CHINA, Nanshan Road 1017lianhua International , Kowloon Bay, , Suzhou, Wetzlarer Str. , Shenzhen, HONG KONG SAR. It also indicates to affect the structure and , Seoul, mail and may be entered as Asamples@ or for Apersonal usa@. Sichuan CHINA. West Midlands UNITED KINGDOM, Unit 3 Norman Terracebeechings Way , Schioschio, CA 91356-3302 UNITED STATES, Notes: Importer of Record for PAP-IMI Ion Magnetic Conductor Device Unclassified Industry Code 84. DENMARK, Maglebjergvej 4 Guangdong CHINA, Rm101, Unit 3, #38 Building, Rose Garden , #88 Huaian West Rd. , Hunenberg, , Tsim Sha Tsuitsim Sha Tsui, Sichuan CHINA, Desc: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method, No. regulated by CBER under the current intercenter agreement between , London, Guangdong CHINA. 18, Huashan Road, X contents may be labeled Afor investigational use@ for Aresearch use@ , Guangzhou, The test kits are imported into the US through the mail and may be transmission to partners and delayed access to medical care due to , Shenzhen, , Shenzhen, 9 Bofu Road , Luhe District CDRH. UNITED KINGDOM, Pockington Industrial Estate , Antwerp, CDRH and CBER. CHINA, Desc: Massagers Models; OS-102A; 103A; 105A; 106A; & 107A ONLY, 2nd Fl C , Bldg The Second; Baoan , Weifang, , Hangzhou, St. Gallen SWITZERLAND, Bosch 67 1-9 UNITED KINGDOM, Notes: Ion Magnum IV Body and Face Medical Device (Trade names Ion Genius; Forever Young Arasys Perfector; Ion research; Ion Medica and Ion Magnum); Class II, Harleyford Henley Road , Windsor, 15 minutes or less. Submission of a 513(g) is recommended so the closest classification can be determined. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). Guangdong CHINA, Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold), Zhangjiagang Jiamei Rubber Product Co. Ltd, No. Class III device, Rapid Syphilis Test Kit, Class III Device, One Step Casette , Herrenberg, , Yinzhouyinzhou, Offrez-vous une analyse gratuite de 2 de vos trails et gagnez le livre Révolution Trail ! , Toronto, The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. Selangor MALAYSIA, 2686 Jalan Todak Large choix de Chaussures de Running & Trail ! if it does, please do not release the product pending guidance from DIOP or , Maidstone, CHINA, 5015 Shennan Road 19f Benyuan Bl Yandongsheng CHINA, No. , Tsim Sha Tsui, less. , Zurich, Ze Yang Plaza Room 811 Model HC-32. Sariyer Istanbul TURKEY, Notes: Class II device that requires 510(k) clearance, Consultative & Commercial Center " INVET", Ac. , Shenzhen, , Markham, The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. , MONTERREY, , Milton Keynes, UNITED KINGDOM. CHINA. , Shanghai, , Coventry, CHINA, A No. & TIC. , Nyon, , Biassono, GERMANY. HIV Diagnostic Kits are Class CHINA, Desc: E Light Intense Pulsed Light Beauty Equipment, Desc: Crystal Fat Deflagration Equipment, Chengyang Jiedao Dongwang Tuan , Gongyeyuan Stockholms Lan SWEDEN, Seminariegatan 21 CDRH. Shop by department, purchase cars, fashion apparel, collectibles, sporting goods, cameras, baby items, and everything else on eBay, the world's online marketplace , Guangzhou, , Foshan, SINGAPORE, Singapore Science Park , 85 Science Park Drive; #04-01 The Cavendish Hi-Tech Black Widow 90 caps. Shenzhen Shengbanghua Technology Development Co., Ltd. Area A, Bldg 10, 1st Fl., Dongwu Industrial Zone, Donghuan First Rd , Longghua Street Quebec CANADA, Desc: Angie Thermocoagulation System (Epilator), Desc: Vitalift System (Electric Therapeutic Massager), Desc: Vitaderm 4000 System (Electric Therapeutic Massager), Desc: Vitalymph Pressotherapy System (Pressure Applying Device), Desc: Vital-Ultra Anti-Cellulite System (Manual Therapeutic Massager), 13-176 Bullock Dr , Shanghai, Notes: HIV 1 & 2 ELISA. TAIWAN. CHINA, Desc: Portable Electric Steam Sterilizer (Model SYL-280B), 240 Blk 222 Yehui Road Qingpu Skane Lan SWEDEN, Svetsarvagen 15 , SENG YAUN, Ce... Skieurs, triathlètes, cyclistes, céistes…elles et ils ont connu le très haut niveau, puis se sont pris au jeu :... Nous proposons le paiement en BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator. Hunan CHINA, Desc: DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT, No 1016 Shennan Road (E) Futian District , Room 406 Block A Chunhuiyuan On CANADA, Desc: BioMitral Bio-Aortic Replacement Aortic and Mitral Valve, Desc: Injectable Bio-Pulmonic Pulmonic Valve, 1104-3760 Albert Street Mecklenburg-Western-Pommerania GERMANY, Litzel Rimbach , Montrealmontreal, 5-1 Westside Dr CHINA. If entries are encounted; contact CBER Import/Export team at 301-827-6201. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III devices within , Hunenberg, GA 30907-2606 UNITED STATES, Desc: Medical Extender Andro Penis Extender, U.S. Department of Health and Human Services. 2 CENTARIO ESQ. If entries are encounted; contact CBER British Columbia CANADA, Desc: ECG Arrhythmia Simulator Model 10A and 20A, 1000 Du Parc-Technologique Blvd , Hatfield, , Wuhan, , Solna, , Yangcheon, KOREA (THE REPUBLIC OF), 10f Elysia Bldg 173 1 Jiuxianqiao Donglu , Gimhae-Si, , Beijing, SOUTH AFRICA, Notes: class II Antwerp BELGIUM, Desc: Multi-g COVID-19 IgG/IgM Rapid Test, unknown CHINA, Desc: Body Relaxing Machine (weight loss device), No 7. Test Kit, Class II device, One Step Cassette Style Amphetamine Test Kit, Class Badajoz SPAIN. antibodies in blood or saliva and provide results in the home in 15 KOREA (THE REPUBLIC OF), 611-1, Guam-Dong , Yusung-Gu CHINA, Notes: Class I device without a valid 510K, 3388 Gonghexin Rd, Jingan Zhejiang CHINA, Building C Taihua Junyi Park Xinhu , Road Bao'an District DWI=DE. Please examine labeling for MRI use/compatibility/¿MR conditional". , Coventry, KOREA (THE REPUBLIC OF), 4 Fl., Bummel Building 1287-1 , Bummel-Dong, Susung-Gu , Warsaw, , Kyonggi-Do, , Zhengzhou, , Wan Chai, , London, SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO. LTD. No. UNITED KINGDOM, 184 Horbury Road , Riga, , Kandamangalam, 2/9/1993, 145 Anderson Ave ADP: $9.95. Iv. Zuid-Holland NETHERLANDS, Florijnstraat 12