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

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RecordFirmDate
SPQ(TM) TEST SYSTEM FOR PREALBUMIN (K884297)Atlantic Antibodies1988-11-02
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES (K883747)Diagnostic Products Corp.1988-11-01
SONY COLOR VIDEO CAMERAS AND ACCESSORIES (K884343)Sony Corp. of America1988-11-01
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) (K883878)Amersham Corp.1988-11-01
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (K884357)Precision Dynamics Corp.1988-11-01
MSI STANDARD BED MODELS: L1097-64 AND L1085-64 (K881961)Med Service, Inc.1988-11-01
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER (K883539)Serono-Baker Diagnostics, Inc.1988-10-31
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) (K883267)Diagnostic Products Corp.1988-10-31
BEHRING TURBITIMER (K883646)Behring Diagnostics, Inc.1988-10-31
PL 20/20 INFANT VISION TESTER (K883337)Optimed Technologies, Inc.1988-10-31
ROCKET INTRAUTERINE SOUND (K883806)A & A Medical, Inc.1988-10-31
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT (K882629)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-31
UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4 (K883961)Unimax Hearing Instruments1988-10-31
HI CHEM KINETIC CHOLESTEROL REAGENT #88218 (K883844)Hichem Diagnostics1988-10-31
GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT (K884052)Professional Service Unltd.1988-10-26
CHEM 1 UIBC (IRON BINDING CAPACITY TEST) (K883104)Technicon Instruments Corp.1988-10-25
STREPSLIDE (K882811)Ncs Diagnostics, Inc.1988-10-25
FDL ELISA FOR CHLAMYDIA (K883266)Fairleigh Dickinson Laboratories, Inc.1988-10-25
OXALATE REAGENT (K883525)Sigma Chemical Co.1988-10-25
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (K884208)Oxoid U.S.A., Inc.1988-10-25
FIBER OPTIC LARYNGOSCOPE (K883830)Effner, Inc.1988-10-25
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K883083)Medical Diagnostic Technologies, Inc.1988-10-25
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II (K882486)Bio-Rad1988-10-25
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST (K883321)Heraeus Kulzer, Inc.1988-10-25
KRATZ NOVA SERT(TM) (K883489)Coopervision-Cilco1988-10-25
SNAP N' STAIN IODINE STAIN (K884069)Scientific Device Laboratory, Inc.1988-10-25
PMD SYSTEM-20 (K883390)Datatek, Inc.1988-10-25
DENTA PLUS (K883403)Connoisseurs Products Corp.1988-10-25
CDT CYTOTOXI TEST (K883560)Advanced Clinical Diagnostics1988-10-25
BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 (K883131)Advanced Mechanical Technology, Inc.1988-10-24
BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 (K883130)Advanced Mechanical Technology, Inc.1988-10-24
BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 (K883129)Advanced Mechanical Technology, Inc.1988-10-24
GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) (K884195)Mumtaz I. Malik1988-10-24
BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM (K883198)Advanced Mechanical Technology, Inc.1988-10-24
MICRO-X 100CP (K884134)Fischer Imaging Corp.1988-10-21
COMFORT STRAP (K884149)Comfort Strap Co.1988-10-21
REPORT AND IMAGE MANAGEMENT SYSTEM (K882754)Medical Image Processing Specialists, Inc.1988-10-21
MOUTH-TO-MASK VENTILATORY ADJUNCT (K883766)Medic One1988-10-21
BALLET STERILE DISPOSABLE ELECTROLYSIS (K883892)Synoptic Products1988-10-20
QM300 APOLIPOPROTEIN B ANTIBODY PACK (K883714)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
SCISSORS, WIRE CUTTING (K884095)Magnatrade Corp.1988-10-19
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK (K883713)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
RADKOR SFR-70 (K883864)Radkor, Inc.1988-10-19
FLOSER PLUS (K884145)Pacific Lin Intl., Co.1988-10-19
CLOSED WOUND SUCTION DEVICE (K883472)Westmark, Sterile Packing Systems, Inc. (Sps)1988-10-18
BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P (K883819)Circon Acmi1988-10-17
PORTABLE II DENTAL DELIVERY SYSTEM (K883775)Dntl Corp.1988-10-14
STERILE SURGICAL LATEX GLOVES (K883824)Intl. Trading Ventures, Inc.1988-10-13
MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 (K884039)Medical Dynamics, Inc.1988-10-13
RUBBER BAND, STERILE (K882695)Bioseal1988-10-13
ALM OPERATING TABLES (K884019)Alm Surgical Equipment, Inc.1988-10-13
STERI-TAG(TM) STERILE LABEL SETS (K883654)Acacia Laboratories, Inc.1988-10-13
ALLOPREP SYSTEM (K883065)Osteotech, Inc.1988-10-13
TECHNICON RA(TM) SYSTEMS - MAGNESIUM (K883326)Technicon Instruments Corp.1988-10-13
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (K883387)Tech-Co, Inc.1988-10-13
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST (K883861)Casco Standards1988-10-13
LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) (K884073)Eastmed Enterprises, Inc.1988-10-13
NOVASPEC II SPECTROPHOTOMETER (K883435)Pharmacia, Inc.1988-10-13
SURGI-TAG(TM) STERILE LABEL SETS (K884055)Acacia Laboratories, Inc.1988-10-13
HLE-1000 HIGH/LOW TREATMENT TABLE (K883659)Rich-Mar Corp.1988-10-13
LARYNGOSCOPE (K883296)Lothar Scharras1988-10-13
KVM HEMOGLOBIN LYSING REAGENT (K883991)Kvm Technologies, Inc.1988-10-12
TRACER BONE MILL (K883183)De Medica Mfg., Inc.1988-10-12
DENTAL CHAIR (K883437)E.F. Brewer Co.1988-10-12
KVM ISOTONIC FLUSH SOLUTION (K883989)Kvm Technologies, Inc.1988-10-12
X-ACT LDC/IND (K883996)Pro-Lab, Inc.1988-10-12
KVM ISOTONIC DILUENT (K883990)Kvm Technologies, Inc.1988-10-12
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS (K883792)Catachem, Inc.1988-10-12
STERILE SURGEONS GLOVES (K883736)Medical Manufacturers Marketing Co.1988-10-12
TONOMITOR (TM) + SUMP (K883234)Tonometrics, Inc.1988-10-12
QUIDEL GROUP A STREP TEST (K883999)Quidel Corp.1988-10-12
KOLYNOS DENTAL FLOSS (K882571)Whitehall Laboratories, Inc.1988-10-12
X-ACT UREA/TDA (K883995)Pro-Lab, Inc.1988-10-12
TECNOL BUCKS TRACTION W/HEEL PROTECTOR (K884132)Technol, Inc.1988-10-11
PROTECT-AIDS AUTOPSY UNDERGLOVE (K880440)Medical Armor Corp.1988-10-11
PROTECT-AIDS UNDERGLOVE (K880439)Medical Armor Corp.1988-10-11
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA (K882736)Amersham Corp.1988-10-11
SUREBREATH DOME (K884076)Ipax, Inc.1988-10-07
15 MILLIMETER MALE AND FEMALE ADAPTERS (K884072)Eastmed Enterprises, Inc.1988-10-07
WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE (K883876)E.G. Dick & Assoc.1988-10-07
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR (K883483)Autoflow Products, Co.1988-10-07
B. FRAGTEX (K881380)American Biomedical Products, Inc.1988-10-06
HISTO-CHECK FUNGAL CONTROL SLIDES (K883570)Val Tech Diagnostics, Inc.1988-10-06
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (K883352)Whittaker Bioproducts, Inc.1988-10-06
HISTO-CHECK LEGIONELLA CONTROL SLIDES (K883567)Val Tech Diagnostics, Inc.1988-10-06
FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (K884031)Regency Biotech1988-10-06
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY (K883305)Binax, Inc.1988-10-06
HISTO-CHECK GRAM NEGATIVE SLIDES (K883569)Val Tech Diagnostics, Inc.1988-10-06
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 (K882728)Amersham Corp.1988-10-06
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL (K883147)Utak Laboratories, Inc.1988-10-06
HISTO-CHECK PARASITIC CONTROL SLIDES (K883571)Val Tech Diagnostics, Inc.1988-10-06
DENTREK BRIDGE BARS (K883388)Dale T. Dupuis1988-10-06
HISTO-CHECK ACID FAST SLIDES (K883568)Val Tech Diagnostics, Inc.1988-10-06
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST (K882199)Auspharm Intl. , Ltd.1988-10-06
SNAP N' STAIN IRON STAIN (K884011)Scientific Device Laboratory, Inc.1988-10-06
BREVET DENTAL INSTRUMENTS (K883126)Brevet, Inc.1988-10-05
MEDICAL GLOVES STERILE LATEX SURGEONS DIGIFORM (K882595)Marathon Management Co.1988-10-04
MODEL CBX EPILATOR (K884079)R. A. Fischer Co. Corp.1988-10-04
MEDALIST EXAMINATION TABLE (K883680)Hamilton Industries, Inc.1988-10-04
QTEST PREGNANCY TEST CONTROL (K883741)Quidel Corp.1988-10-03
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