FDA 510(k) Applications Submitted by Ji Ma
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K202108 |
07/30/2020 |
External Counterpulsation System, Soulaire |
Vamed Medical Instrument Co., Ltd. |
K000027 |
01/05/2000 |
INSUFFLATION NEEDLE, MODEL R65-933 |
A & A MEDICAL, INC. |
K010056 |
01/08/2001 |
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 |
A & A MEDICAL, INC. |
K010789 |
03/15/2001 |
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 |
A & A MEDICAL, INC. |
K973671 |
09/26/1997 |
ENDOCERVICAL BLOCK NEEDLE |
A & A MEDICAL, INC. |
K974032 |
10/23/1997 |
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR |
A & A MEDICAL, INC. |
K974038 |
10/24/1997 |
THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT |
A & A MEDICAL, INC. |
K974138 |
11/03/1997 |
ROCKET ELECTRODE |
A & A MEDICAL, INC. |
K994256 |
12/17/1999 |
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 |
A & A MEDICAL, INC. |
K003949 |
12/21/2000 |
TACKER, MODEL R65-933 |
A & A MEDICAL, INC. |
K010296 |
01/31/2001 |
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 |
MARINA MEDICAL INSTRUMENTS, INC. |
K010510 |
02/21/2001 |
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 |
A & A MEDICAL, INC. |
K011512 |
05/16/2001 |
MMODIFICATION TO LAMINARIA |
A & A MEDICAL, INC. |
K220383 |
02/10/2022 |
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) |
Okami Medical |
K203025 |
10/02/2020 |
LOBO Vascular Occlusion System (model LOBO-5) |
Okami Medical |
K072095 |
07/31/2007 |
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS |
SYNTHES (USA) |
K073135 |
11/07/2007 |
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS |
SYNTHES (USA) |
K080109 |
01/15/2008 |
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM |
SYNTHES (USA) |
K081452 |
05/23/2008 |
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM |
SYNTHES (USA) |
K082148 |
07/30/2008 |
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION |
SYNTHES (USA) |
K082650 |
09/12/2008 |
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL |
SYNTHES (USA) |
K082807 |
09/24/2008 |
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS |
SYNTHES (USA) |
K201610 |
06/15/2020 |
IonicRF Generator |
Abbott Medical |
K960038 |
01/03/1996 |
SPECTRUM DESIGNS SILICONE BLOCK |
SPECTRUM DESIGNS, INC. |
K980140 |
01/15/1998 |
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT |
SPECTRUM DESIGNS, INC. |
K980138 |
01/15/1998 |
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
K980139 |
01/15/1998 |
SPECTRUM DESIGNS PROFILE MALAR IMPLANT |
SPECTRUM DESIGNS, INC. |
K980141 |
01/15/1998 |
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT |
SPECTRUM DESIGNS, INC. |
K980444 |
02/05/1998 |
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
K980445 |
02/05/1998 |
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
K980446 |
02/05/1998 |
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
K980462 |
02/05/1998 |
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
K980463 |
02/05/1998 |
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
K980461 |
02/05/1998 |
SPECTRUM DESIGNS CLEFT CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
K970702 |
02/26/1997 |
SPECTRUM DESIGNS SPECTRAGEL |
SPECTRUM DESIGNS, INC. |
K992522 |
07/28/1999 |
SPECTRUM DESIGNS SPECTRAGEL |
SPECTRUM DESIGNS, INC. |
K982688 |
08/03/1998 |
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK |
SPECTRUM DESIGNS, INC. |
K973376 |
09/08/1997 |
LORI/LORI, LORI-S (LORI STOCK AID) |
LORI MEDICAL LABORATORIES, INC. |
K973442 |
09/11/1997 |
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES |
MEDELEC, INC. D.B.A. TECA CORP. |
K000011 |
01/03/2000 |
MODIFIED HYDROPHILIC COATED GUIDEWIRE |
LAKE REGION MFG., INC. |
K011084 |
04/10/2001 |
MANDREL GUIDEWIRE ASSEMBLY |
LAKE REGION MFG., INC. |
K003483 |
11/09/2000 |
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) |
LAKE REGION MFG., INC. |
K060187 |
01/24/2006 |
TOPSLANE DMLC |
TOPSLANE INTERNATIONAL, LLC |
K972065 |
06/03/1997 |
AURORA |
NEUROVENA CORP. |
K150842 |
03/30/2015 |
JUSHA-M53 Medical Display |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
K202670 |
09/14/2020 |
Nam illumination probe with chopper |
Oculight Ltd. |
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