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

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RecordFirmDate
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION (K915684)Rexton, Inc.1992-01-09
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 (K914255)Bio-Rad1992-01-09
GEN-X 800/300 (K915339)Swissray Finatech, Inc.1992-01-09
IL TEST(TM) HDL CHOLESTEROL (K914811)Instrumentation Laboratory CO1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 49 (K915518)Sonotone Intl., Inc.1992-01-09
PRESSURE INFUSER (K913751)Biomedical Dynamics, Inc.1992-01-09
GEN-X 800/500 (K915227)Swiss Ray Medical Systems1992-01-09
MED-EQUIP CORPORATION (K915076)Medequip Co.1992-01-09
DSL INSULIN RIA (DSL 1600) (K914820)Diagnostic Systems Laboratories, Inc.1992-01-09
712 PLASTIC SURGERY TABLE & ACCESORIES (K915141)Midmark Corp.1992-01-09
RIONET HEARING AID HB-52AS (K915319)Rion Co. Ltd. Dba Rion Acoustic Device1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 45G (K914899)Sonotone Hearing Instruments1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 47I (K914898)Sonotone Hearing Instruments1992-01-09
CUSHION, WHELCHAR AND FLOTATION (K915629)Invacare Corp.1992-01-09
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION (K915683)Rexton, Inc.1992-01-09
PAM PLUS (K913998)Kinetic Concepts, Inc.1992-01-08
EXTENDO-BAC TABLE (K914769)Reinert Technics, Inc.1992-01-08
SUTTER MODEL 10000 LEG CPM DEVICE (K914860)Sutter Corp.1992-01-08
ORS-1000 (K915427)Mnlase, Inc.1992-01-07
PATIENT EXAMINATION GLOVEWS (K913531)Pt. Sarana Indoprotex1992-01-07
MOSSIMO OPTIC EYEWEAR (K912509)Mossimo, Inc.1992-01-06
NSN #6545-00-656-1093 KIT, FIRST AID (K914478)Cooperative Workshops, Inc.1992-01-06
GRIESHABER THREE FUNCTION MANIPULATOR (K914586)Grieshaber & Co.1992-01-03
GRIESHABER TWO FUNCTION MANIPULATOR (K914585)Grieshaber & Co.1992-01-03
BIOPSY FORCEPS (K914497)Surgitek Medical Engineering Corp.1992-01-03
BIO-RAD TOTAL PROTEIN TEST KIT (K913315)Bio-Rad1992-01-02
QUALICHECK 4 (K915399)Radiometer America, Inc.1992-01-02
PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) (K914407)Promedex, Inc.1991-12-31
SPECTACLE FRAMES (K914413)Mikado Ca.1991-12-31
CHEM-SLEEVE B (K912257)Haz-Med, Inc.1991-12-31
GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (K914913)Ideal Medical, Inc.1991-12-31
PYRAMID SUNGLASSES/READING GLASSES (K914425)Pyramid1991-12-31
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES (K915461)Phonak, Inc.1991-12-30
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (K912740)Visionary Systems, Inc.1991-12-30
AESCULAP SURGICAL ACCESSORIES (K913262)Aesculap, Inc.1991-12-30
FUN FLOSS (K914962)Fun Floss Co.1991-12-30
FRAMES (SPECTACLES) VARIOUS TYPES (K914614)Match Optical Co.1991-12-30
DIGITRAPPER MARK III (K913387)Synectics-Dantec1991-12-27
VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM (K915094)Vortech Data, Inc.1991-12-27
MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP (K915353)Matrix Medica, Inc.1991-12-27
CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH (K914316)Medi-Flex Hospital Products, Inc.1991-12-24
LULMITEX NEONATAL TRANSILLUMINATOR (K912747)Lumitex, Inc.1991-12-24
PATIENT EXAMINATION GLOVES (K914284)K-International Exports Pvt. , Ltd.1991-12-23
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT (K911880)Bill Olson Corp.1991-12-20
THE BODY BUGGY (K915361)Innova Corp.1991-12-20
SERENA WHEELCHAIR CUSHIONS (K915368)A & C Medical Supply1991-12-20
SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE (K912418)Micromedics, Inc.1991-12-20
PREALBUMIN IMMUNOLOGICAL NL TEST KIT (K913672)The Binding Site, Ltd.1991-12-20
OPTIMA (K913222)Olympic Controls Corp.1991-12-20
TOUCH N TONE 1 MASSAGER (K915242)Conair Corp.1991-12-20
MOLAR DISTALIZING ASSEMBLY (K912417)American Orthodontics1991-12-20
TALLEY SD.500 SKIN PRESSURE EVALUATOR (K914780)Talley Group, Ltd.1991-12-19
MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (K914758)Mdt Corp., Inc.1991-12-19
OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (K914776)Talley Group, Ltd.1991-12-19
POWER FLOSS AND BRUSH EW 129 & EW 120 (K914198)Matsushita Electric Co.1991-12-18
ASPIRATING ENDO OCULAR PROBE (K914247)Surgical Technologies, Inc.1991-12-18
ABBOTT QUICKSTART CHOLESTEROL TEST (K913565)Em Diagnostic Systems, Inc.1991-12-18
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN (K905488)Ausonics Pty , Ltd.1991-12-18
RAI-TROL ELEVATED LIPIDS CONTROL (K915191)Reagents Applications, Inc.1991-12-18
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 (K915208)Medix Biotech, Inc.1991-12-18
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB (K904556)Boston Scientific Corp1991-12-18
VIRAPURE, CHLAMYPURE AND MYCOPURE (K914894)Microtest1991-12-18
IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (K914171)Tech Intl. Co.1991-12-18
URIC ACID (URICASE) REAGENT, UNIVERSAL (K912028)Enzyme Technology, Inc.1991-12-18
MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE (K915393)Mdt Corp., Inc.1991-12-17
INFLUENZA MAB TEST/INFLUENZA A TEST (K913351)Gull Laboratories, Inc.1991-12-17
MIDAS BRACKET (K914003)Gold'N Braces, Inc.1991-12-16
FRAMES (SPECTACLES) (K914239)Jane Fui Optical Co., Ltd.1991-12-16
TROCAR CATHETER (K913678)Medovations, Inc.1991-12-16
DRESSING/CVP DRESSING CHANGE/HYPERALIMENT TRAYS (K914157)Cml, Inc.1991-12-13
INFLUENZA MAB TEST/INFLUENZA B TEST (K913214)Gull Laboratories, Inc.1991-12-13
CHROMATOGRAPHY CLINICAL USE 75JQR (K914841)Millipore Corp.1991-12-10
RSV-MAB TEST (K912842)Gull Laboratories, Inc.1991-12-09
DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) (K914245)Dale Medical Products, Inc.1991-12-09
F055 B.O. FANTASTIC RELAXER (K914707)Fairform Mfg., Co., Ltd.1991-12-09
RANGE OF MOTION SENSOR, MODEL RM001 (K914060)Nk Biotechnical Engineering Co.1991-12-09
F383 RECHARGEABLE MINI MASSAGER (K914703)Fairform Mfg., Co., Ltd.1991-12-09
NK RANGE OF MOTION SENSOR, MODEL RM002 (K914061)Nk Biotechnical Engineering Co.1991-12-09
A101 LITESSAGER (K914830)Fairform Mfg., Co., Ltd.1991-12-09
FO92 SEATING MASSAGER (K914829)Fairform Mfg., Co., Ltd.1991-12-09
FO69 FANCY MASSAGER (K914704)Fairform Mfg., Co., Ltd.1991-12-09
FO51/F151 GOLF MASSAGER (K914706)Fairform Mfg., Co., Ltd.1991-12-09
FO41 BODY MASSAGER (K914705)Fairform Mfg., Co., Ltd.1991-12-09
NK DEXTERITLY BOARD, MODEL BX001 (K914062)Nk Biotechnical Engineering Co.1991-12-09
LATEX EXAMINATION GLOVES (K912040)Pt. Indoraya Everlatex1991-12-09
PHILIPS P74P BEHIND-THE-EAR HEARING AID (K915252)Philips Hearing Instruments Co.1991-12-05
BANDAGE ROLL, GAUZE (K913779)Keilei Intl., Inc.1991-12-04
PROMEON 63B SURGICAL TAPE (K914912)Promeon1991-12-04
MULTIPLE BURN DRESSING (K914071)Kerma Medical Products, Inc.1991-12-04
SORBSAN TOPICAL WOUND DRESSING (MODIFIED) (K914575)Dow B. Hickam, Inc.1991-12-04
GAUZE BANDAGE ROLL (K914842)Cal West Trading Co.1991-12-04
ALGINATE FIBER (K914779)Adri/Technam1991-12-04
STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES (K914937)Kerma Medical Products, Inc.1991-12-04
OPHTHALMIC STAND (K913961)Luneau Ophtalmologie SA1991-12-04
SECURODRIP (K912660)Op-Co Medical Products , Ltd.1991-12-04
EVACU SLED (K913520)Nexus Health Care Products , Ltd.1991-12-04
ABSORBENT FIBER (K914431)Ulti-Med Intl., Inc.1991-12-04
KODAK MIN-R IDENTIFICATION CAMERA (K915088)Eastman Kodak Company1991-12-02
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (K914944)Bennett X-Ray Corp.1991-12-02
REPEL(TM) LITE CUT RESISTANT GLOVE LINERS (K914077)Depuy-Raynham1991-12-02
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