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

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RecordFirmDate
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (K920556)Hybritech, Inc.1992-07-17
TESTPACK PLUS STREP A (K922345)Abbott Laboratories1992-07-16
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) (K921939)Heraeus Kulzer, Inc.1992-07-16
INTRADUCER (K921934)Taut, Inc.1992-07-15
AMRAD HEL-PTEST (K920827)Amrad1992-07-14
ESP BLOOD CULTURE SYSTEM (K921637)Difco Laboratories, Inc.1992-07-14
NK MEDICAL MICROMETER, MODEL MC001 (K921266)Nk Biotechnical Engineering Co.1992-07-14
BLOOD GAS/ISE LINEARITY CONTROL (K920285)Phoenix Diagnostics, Inc.1992-07-14
HOT OR COLD PACK (THERMIPAQ) (K921446)Thermionics Corp.1992-07-13
INDUSTRIAL STRENGTH EYEWEAR (K920701)Grafix Marketing Group1992-07-13
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (K920795)Optical Radiation Corp.1992-07-13
SPINE LINE (K922366)Dambrecine, Inc.1992-07-13
TX ELECTRIC TOOTHBRUSH (K921773)Optiva Corp.1992-07-13
TUMBLE FORMS TRISTANDER (K922965)Tumble Forms1992-07-13
FLEXION DISTRATION SUPPORT (K921711)Altoona Medical Supply1992-07-13
DIGI SPORTLENS SYSTEM (K921444)Fitness Quest, Inc.1992-07-13
KODAK EKTACHEM 250 ANALYER (K922072)Eastman Kodak Company1992-07-10
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID (K922392)A-1 Hearing Aid Lab1992-07-10
GUEDEL AIRWAY (K922748)Oem Medical Div.1992-07-10
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 (K922046)Bio-Rad1992-07-10
ROCHE REAGENT FOR URIC ACID--MODIFICATION (K922762)Roche Diagnostic Systems, Inc.1992-07-09
PATIENT EXAMINATION GLOVES (K921799)Consolex Corp. Sdn. Bhd.1992-07-08
EPISTAXIS NASAL BALLOON CATHETER (K921199)Smith & Nephew Richards, Inc.1992-07-08
DADE URINE CHEMISTRY CONTROL LEVELS I AND II (K920636)Baxter Diagnostics, Inc.1992-07-07
A-ZILICONE (K905555)Oticon Corp.1992-07-06
LEWICKY O.R.S. TUBING (K922180)O.R. Specialties, Inc.1992-07-02
OLYMPUS TRIGLYCERIDE REAGENT (K922229)Olympus Corp.1992-07-02
AGA TRACH TIES (K922657)Aga Medical Products, Inc.1992-07-02
OPERATING TABLE SYSTEM-BETAMAQUET 1140 (K920890)Stierlen-Maquet AG1992-07-02
SUNGLASSES (K920807)Libby Lee Toys, Inc.1992-07-01
SDMO APPLICATOR CODE: ASN.8236 (K921961)Medi-Physics Inc. Dba Nycomed Amersham Imaging1992-07-01
THERMUFF BAG (K920153)Techstyles1992-07-01
TTL MEDICATED DRESSING (K914733)Medimix Products, Inc.1992-07-01
OTOSONIC ACS K (K922827)Beltone Electronics Corp.1992-07-01
AD/V SPOOLER (K921877)Adaptive Video, Inc.1992-07-01
BACTEC 9120 SYSTEM (K922475)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-07-01
BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. (K915786)Helix Medical, Inc.1992-06-30
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (K921624)Intertech Resources, Inc.1992-06-30
RNA MEDICAL'S EQUIL 55 (K922357)Bionostics, Inc.1992-06-30
ORWO X-RAY FILM (K920539)Burkhart Roentgen Intl., Inc.1992-06-30
WIDEX MODEL D32 (K922708)Widex Hearing Aid Co., Inc.1992-06-30
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER (K921661)Boehringer Mannheim Corp.1992-06-30
COXSACKIE VIRUS B1-B6 CF ANTIGENS (K921618)Virion (U.S.), Inc.1992-06-29
MOVIT DEVICE (K921710)John J. Navar, M.D.1992-06-29
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM (K921556)Medical Diagnostic Technologies, Inc.1992-06-29
RNA MEDICAL TONOMETER (K922386)Bionostics, Inc.1992-06-26
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER (K922220)Olympus Corp.1992-06-25
OLYMPUS GGT REAGENT (K922230)Olympus Corp.1992-06-25
SUNGLASSES AND EYEGLASS FRAMES (K920764)New Optic Srl1992-06-25
STATVIEW (K921527)Image Data Corp.1992-06-24
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE (K922612)Cholestech Corp.1992-06-24
BACTON(TM), AUTO-APO A-1 REAGENT (K921795)Bacton Assay Systems, Inc.1992-06-23
LEVY ARTICULATING RETRACTOR (K920471)Lifeguard Medical Products, Inc.1992-06-23
DISPOSABLE LATEX EXAMINATION GLOVES (K921438)Perlink USA, Inc.1992-06-23
MODIFIED SITE POWER HANDPIECE (K922077)Chiron Vision Corp.1992-06-23
BREATH-EASY, MODIFICATION (K914416)Icor AB1992-06-23
MG-1001 TUBE HOUSING ASSEMBLY (K921316)Magma Corp.1992-06-22
MODIFIED ORTHO EBV VCA-IGG ELISA (K920412)Ortho Diagnostic Systems, Inc.1992-06-22
BACTON(TM), AUTO-APO B REAGENT (K921862)Bacton Assay Systems, Inc.1992-06-22
BACTIDROP INDOLE (ERLICH'S) (K920973)Remel Co.1992-06-19
ULTRA-CORE BIOPSY NEEDLES (K921418)Medical Device Technologies, Inc.1992-06-19
KERATOREF L60 (K922253)Luneau Ophtalmologie SA1992-06-19
URINE CULTUR STABILIZATION TRANSPORT TUBE (K920761)Bio Medicus, Inc.1992-06-19
DRYSLIDE(TM), PYR (K921583)Difco Laboratories, Inc.1992-06-19
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 (K920927)Helena Laboratories1992-06-19
HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES (K915086)Hpi, Inc.1992-06-17
ENTENDED LINE ACCESSORIES & CONNECTORS (K921512)Intersurgical, Inc.1992-06-17
CATHETER MOUNTS -- MODIFICATION (K921511)Intersurgical, Inc.1992-06-17
ROTOLUX, SELECTOLUX, SHUTTERVUE (K922079)American Medical Sales, Inc.1992-06-16
SHOWERFLOSS ORAL IRRIGATION UNIT (K922307)Showerfloss, Inc.1992-06-16
BITE RIM WAX (K922380)Dentsply Intl.1992-06-16
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE (K921601)Ultradent Products, Inc.1992-06-16
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921746)Biomerieux Vitek, Inc.1992-06-16
PATIENT EXAMINATION GLOVES (K921376)Seal Polymer Industries Bhd.1992-06-15
NASOPHARYNGEAL AIRWAY (K921353)Coast Medical Corp.1992-06-11
OPHTHALMIC PROJECTOR (K921214)Luneau Ophtalmologie SA1992-06-11
JACE KNEE EXTENSION SYSTEM -- MODIFICATION (K922185)Jace Systems, Inc.1992-06-11
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (K913817)Synectics-Dantec1992-06-11
ORTHO-PLEX-REHABILITATION SYSTEM (K920686)Plexus Intl., Inc.1992-06-11
GAS SAMPLING KIT MODIFICATION (K921510)Respiratory Support Products, Inc.1992-06-11
KNEE PROSTHESIS DRIVER (K915776)Kim-Med, Inc.1992-06-11
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (K914753)United States Surgical, A Division of Tyco Healthc1992-06-11
NEOPROBE PORTABLE RADIOSCOPE DETECTOR (K915279)Neoprobe Corp.1992-06-10
IN THE EAR HEARING AID (K915711)Zenith-Omni H.C., Inc.1992-06-10
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) (K922301)Beltone Electronics Corp.1992-06-10
CHEM CHEX THEOPHYLLINE CONTROL (K920223)Streck Laboratories, Inc.1992-06-10
PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES (K922422)Audioscience, Inc.1992-06-10
SONY LASER VIDEODISC RECORDING SYSTEM (K921275)Sony Medical Systems1992-06-10
4 SURE TM COLOSTOMY POUCH (K922401)Boston Pacific Medical, Inc.1992-06-10
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (K920942)Olympus Corp.1992-06-10
ORS-100 (K921568)Mnlase, Inc.1992-06-09
BACTIDROP INDIA INK (K920976)Remel Co.1992-06-09
BACTIDROP CALCOFLUOR WHITE (K920975)Remel Co.1992-06-09
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 (K921286)Bio-Rad1992-06-09
IMMULITE(R) FSH (K921704)Cirrus Diagnostics, Inc.1992-06-09
ORS-200 (K921569)Mnlase, Inc.1992-06-09
BACTIDROP KOH (10%) (K920970)Remel Co.1992-06-09
SEROELISA(TM) CHLAMYDIA IGA TEST KIT (K914327)Savyon Diagnostics , Ltd.1992-06-09
ORS-300 (K921570)Mnlase, Inc.1992-06-09
CKS OSCILLATING SAW BLADE (K921131)Techmedica, Inc.1992-06-08
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