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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
CHAMP INTERNATIONAL CORP. (K950922)Champ International Corp.1995-03-22
SUNGLASSES (K951080)Taiwan Georgia Corp.1995-03-22
MULTI-WASH (K950324)Multi-Wash Medical, Ltd.1995-03-22
DIACIDE HD DISINFECTING SOLUTION (K944037)Gulfstream Medical1995-03-22
CONTROL III DISINFECTANT GERMICIDE (K944179)Maril Products, Inc.1995-03-22
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 (K944525)Medical Analysis Systems, Inc.1995-03-21
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)Organon Teknika Corp.1995-03-21
MEGA-SIL A-B (K950912)Microsonic, Inc.1995-03-21
MAICO IN-THE-EAR MODEL RD-312 CIC (K950637)Maico Hearing Instruments, Inc.1995-03-21
ELX800 AND EL800 AUTOMATED MICROPLATE READERS (K950104)Bio-Tek Instruments, Inc.1995-03-21
M-29 PP-PC, M-29 PP-O/PC (K950451)Rexton, Inc.1995-03-21
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (K950221)Izon Business Products, Inc.1995-03-21
DYNA 231X (K950758)Phonak, Inc.1995-03-21
UD 150L-R II (K945453)Shimadzu Medical Systems1995-03-21
SII 525 APR (K950040)Scott Imaging Intl., Inc.1995-03-21
DENTOOL (K923780)Dentool, Inc.1995-03-21
SII 360 APR (K950041)Scott Imaging Intl., Inc.1995-03-21
CHEM TRAK ACCUMETER (K943599)Chemtrak, Inc.1995-03-21
UD 150L-F (K945452)Shimadzu Medical Systems1995-03-21
MULTIPLE (IZON URINE COLLECTION KIT) (K950246)Izon Business Products, Inc.1995-03-21
MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS (K951138)Invacare Corp.1995-03-20
KENLOR HUMAN SPINAL FLUID CONTROL (K950326)Kenlor Industries, Inc.1995-03-20
AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830 (K951037)Akisu Machinery1995-03-20
CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL (K950589)Creative Laboratory Products, Inc.1995-03-20
MCINTOSH, MILLER, FOREGGER BABY (K945425)Rudolf Riester GmbH & Co. KG1995-03-20
TRIP CIC CATHETER (K920849)Tonometrics, Inc.1995-03-17
VACSTAR (K942698)Air Techniques, Inc.1995-03-17
CONQUEST MALE CONTINENCE SYSTEM (K942941)Convatec, A Bristol-Myers Squibb Co.1995-03-17
FLEXSYS MOBILEMATE EQUIPMENT STAND (K944580)Hill-Rom, Inc.1995-03-17
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM (K945719)Sherwood Medical Co.1995-03-16
VISTACAM (K943204)Air Techniques, Inc.1995-03-16
SURGICAL INSTRUMENT GUIDE (K950007)United States Surgical, A Division of Tyco Healthc1995-03-15
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT (K943150)Genzyme Corp.1995-03-15
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD (K950180)E.I. Dupont DE Nemours & Co., Inc.1995-03-15
BACK SPECIALIST (K944329)Health Care Mfg., Inc.1995-03-15
RITE-BITE BIOPSY FORCEPS (K951048)Mill-Rose Laboratory1995-03-15
ANGIOCATH SIDEHOLDER DRAINAGE CATHETER (K950437)Becton Dickinson Vascular Access, Inc.1995-03-14
HILTON, BENTLY SET, SENATOR, MAYFAIR MATCH AND MONSIUR (K950938)Rahddim, Inc.1995-03-14
INSYTE SIDEHOLDED DRAINAGE CATHETER (K950439)Becton Dickinson Vascular Access, Inc.1995-03-14
CARDON PHYSICAL THERAPY TABLES MODELS: R27610 (K950874)Cardon Rehabilitation Products, Inc.1995-03-14
MYCOAKT M. AVIUM CULTURE ID KIT (K943049)Dynagen, Inc.1995-03-13
MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (K943051)Dynagen, Inc.1995-03-13
MYCOAKT M KANSASII CULTURE ID KIT (K943050)Dynagen, Inc.1995-03-13
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (K941427)Teco Diagnostics1995-03-13
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED (K942458)Randox Laboratories, Ltd.1995-03-13
PICCOLO(TM) (K942782)Abaxis, Inc.1995-03-13
DISPOSABLE ADHESIVE FACE MASK (K950771)Advanced Warming Systems, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM (K946288)Copan Diagnostics, Inc.1995-03-10
SPINALPLANE (K934336)Synvasive Technology, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM (K946286)Copan Diagnostics, Inc.1995-03-10
STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 (K942694)Biodex Medical Systems, Inc.1995-03-10
KRDL 2000 (K944819)Physicians Consulting, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM (K946285)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM (K946283)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K946284)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K946287)Copan Diagnostics, Inc.1995-03-10
STAT PROFILE PLUS 9 ANALYZER (K936066)Nova Biomedical Corp.1995-03-09
TCD OR TCD NEUROPATHY STAR (K944234)Jcm Management & Planning Co.1995-03-08
TRAV-LER KIT (K943942)John O. Butler Co.1995-03-08
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG (K946043)Rudolf Riester GmbH & Co. KG1995-03-08
SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED) (K943255)Wembley Rubber Products (M) Sdn Bhd1995-03-07
KAO YING (K946010)Kao Ying Industrial Co., Ltd.1995-03-07
MEDI PLUS SURGEON'S GLOVES (K945363)P.T. Saptindo Surgica1995-03-07
KARMA WHEELCHAIR (K950195)Karman Healthcare, Inc.1995-03-07
THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES (K950655)Ultrassage, Inc.1995-03-07
RESOUND(R) RESOURCE(TM) (K945750)Resound Corp.1995-03-07
BBLCRYSTAL ANAEROBE ID SYSTEM (K944528)Becton Dickinson Microbiology Systems1995-03-07
COMFIT BLUE POWDER FREE EXAMINATION GLOVES (K943563)Wembley Rubber Products (M) Sdn Bhd1995-03-07
SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED) (K943254)Wembley Rubber Products (M) Sdn Bhd1995-03-07
RECHARGEABLE BATTERIES (K944521)R & D Batteries, Inc.1995-03-06
MODULAR BIOPSY FORCEP (K946360)Cox Medical Ent., Inc.1995-03-06
UCB (K950689)Cox Medical Ent., Inc.1995-03-06
R&D PART NOS. 5262, 5543, 5432, 5469 (K945868)R & D Batteries, Inc.1995-03-06
CANDELA URETHRAL/BLADDER SOUND (K950633)Candela Laser Corp.1995-03-06
SILON(R) SILICONE THERMOPLASTIC SHEETING (K945892)Bio Med Sciences, Inc.1995-03-03
PREMIER(TM) H. PYLORY (K945558)Meridian Diagnostics, Inc.1995-03-03
MICROPLATE PROCESSOR 3000 (K945135)Organon Teknika Corp.1995-03-03
NON-PRESCRIPTION SUNGLASSES (K945922)Csi Industries, Inc.1995-03-03
KT1000/S KNEE LIGAMENT ARTHROMETER (K943197)Medmetric Corp.1995-03-02
ORVIS KEY WEST SUNGLASSES (K950609)The Orvis Co., Inc.1995-03-02
POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES (K945767)Ansell, Inc.1995-03-02
METAL FRAME, PLASTIC FRAME (K945895)Sun Vista Intl., Inc.1995-03-02
R&D BATTERIES PART NOS. 5186 AND 5230 (K944387)R & D Batteries, Inc.1995-03-02
SUNGLASSES (K950526)Tony Optical Enterprises Co., Ltd.1995-03-02
SILHOUETTE SUNLIMITED ADIDAS (K950519)Silhouette Optical , Ltd.1995-03-02
S & S ORTHOPEDIC WIRE DRIVER 701 (K944488)S & S Orthopedic , Ltd.1995-03-02
TUNNELER (K943968)Denver Biomedicals, Inc.1995-03-01
NON-PRESCRIPTION SUNGLASSES (K950391)Aceway Sunglasses Corp.1995-03-01
SURGICAL BUR (K950449)Transidyne General Corp.1995-03-01
BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS (K945832)Brady Medical Products Co.1995-03-01
KBTC (K950720)Kyong-Buk Trading Corp.1995-03-01
VIDEO VISION ANALYZER (VIVA), VRB 100 (K945959)Tomey Corporation USA1995-03-01
MARTIN SUNGLASSES (K950456)Jack Martin Co., Inc.1995-03-01
CHILDREN'S SUNGLASSES (K950226)Consolidated Stores Corp.1995-03-01
SPIRIT II AND SPIRIT TREATMENT CENTER (K946187)Pelton & Crane Co.1995-03-01
OP-D-OP II (K945098)Op-D-Op Visor Shields, Inc.1995-02-28
DISPOSABLE LATEX EXAM GLOVES (K941557)Dah Lee Investments, Ltd.1995-02-28
DERMAGRAN WOUND CLEANSER WITH ZINC (K945802)Derma Sciences, Inc.1995-02-27
STERI-LUB LUBRICATION GEL (K944969)Horizon Medical, Inc.1995-02-27
R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 (K944390)R & D Batteries, Inc.1995-02-27
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