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

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RecordFirmDate
ENEMA BULB (K904534)R.A.C., Inc.1990-12-21
HEARSET TELEPHONE HEARING SYSTEM (K903145)Starkey Laboratories, Inc.1990-12-21
HIGH RISK (K903559)Medical Resources, Ltd.1990-12-21
SEROFAST (K903958)Intl. Mycoplasma/Mdc Assoc.1990-12-21
QAR HANDPIECE (K904671)Collagen Corp.1990-12-21
ELLIPSE 2.3 (K905621)Everest & Jennings, Inc.1990-12-21
PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY) (K905585)Pioneer Trading Co.1990-12-21
STERILE SURGICAL GLOVES/DOUBLE GLOVER (K905012)American Advisors, Inc.1990-12-21
CHIROFLEX FORCEPS (K903575)Chiron Ophthalmics1990-12-21
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF (K903132)Ortho Diagnostic Systems, Inc.1990-12-21
ANEROID BLOOD PRESSURE GAUGE (K904376)Biomedical Dynamics, Inc.1990-12-20
RAICHEM GGT REAGENT (K905085)Reagents Applications, Inc.1990-12-20
KETOREX SANWA STANDARDS (K903365)Ihara Medics U.S., Inc.1990-12-20
YANKAUER SUCTION DEVICE (K905478)Medovations, Inc.1990-12-19
BONE RASPS (K905187)Micro Surgical Instruments Corp.1990-12-19
ZOETIC GLOVES (K905515)Janco Polymers Pvt., Ltd.1990-12-19
ANESTHETIC GAS CALIBRATION MIXTURE (K902754)Liquid Air Corp.1990-12-19
DERMABRADER (K905046)Aaron Medical Industries1990-12-19
PATIENT EXAMINATION GLOVES (K905550)Medical Device Inspection Co., Inc.1990-12-19
T.C.S. TOTAL CONTACT SEAT (K905013)Fundamental Products Co.1990-12-19
G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN (K902985)Electromek Diagnostic Systems, Inc.1990-12-19
G.E. MSI 850/850II/1250 THREE PHASE GENERATORS (K902988)Electromek Diagnostic Systems, Inc.1990-12-19
CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL (K904781)Cholestrech Corp.1990-12-18
CHOLESTECH L.D.X. LEVEL 1 CONTROL (K904784)Cholestech Corp.1990-12-18
NITRO BLUE TETRAZOLIUM REDUCTION (K904022)Sigma Chemical Co.1990-12-18
VISTEK ELECTRONIC CONTROLLER (K904682)Vistek Corp.1990-12-18
MEMORYMATE HEARING AID WITH PMC PROGRAMMER (K904020)3M Company1990-12-17
SAF FIXATIVE (K905120)Gibson Laboratories, Inc.1990-12-17
SI-PRO (K904389)David F. Trungale1990-12-17
DENTAL VACUUM INJECTION TRAY (K904914)The Lebanon Vac-Tray Corp.1990-12-17
QUALITONE ITE GENESIS (K904731)Qualitone1990-12-17
LUPO-TEST REAGENT (K903037)Gradipore , Ltd.1990-12-17
SCRIBBON (K905382)Varnum Corp.1990-12-17
SALTER LABS MODEL #1015 (K903539)Salter Labs1990-12-17
QUALTEX SKIN MARKER (K904559)Qualtex, Inc.1990-12-13
QUALTURE (K903470)Future Medical Technologies Intl., Inc.1990-12-13
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER (K903519)Intertech Resources, Inc.1990-12-13
1-CUT ACL GRAFT KNIFE (K905380)Depuy, Inc.1990-12-13
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT (K903995)Sigma Chemical Co.1990-12-13
NA NEEDLES (K904667)Olympus Corp.1990-12-12
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (K905284)Amresco, Inc.1990-12-11
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS (K904905)Medical Analysis Systems, Inc.1990-12-11
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (K905226)Enzyme Technology, Inc.1990-12-11
KLEARTEX LATEX SURGEONS GLOVES (K904361)Kleartex Sdn Bhd1990-12-07
CHILDRENS SUNGLASSES (K902225)Jasco Products Co., Inc.1990-12-07
HDL CHOLESTEROL CONTROL (K904872)Analytical Control Systems, Inc.1990-12-07
HEARING AID, UNITRON MODEL UM60-UH (K904576)Unitron Industries, Inc.1990-12-07
LDL-DIRECT CONTROLS (K902740)Isolab, Inc.1990-12-07
BATTERY-POWERED TOOTHBRUSH (K904401)The B & F System, Inc.1990-12-07
QUALITONE ULTRA CANAL GENESIS (K904730)Qualitone1990-12-07
BRACKET, METAL, ORTHODOTNIC (K902809)Masel Industries, Inc.1990-12-07
VARICOSCREEN(TM) (K900404)Promedex, Inc.1990-12-07
TRACH-EZE (K903740)Sorex Medical1990-12-06
SHUR-LOCK ICE WRAP SYSTEM (K904819)Conco Medical Co.1990-12-06
ELEGANCE GH ELISA (K905098)Bioclone Australia Pty , Ltd.1990-12-06
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL (K904829)Analytical Control Systems, Inc.1990-12-06
QCLYTE PROTEIN BASED ISE CONTROL (K904968)Baxter Healthcare Corp1990-12-06
CLINICAL CHEMISTRY CONTROL (K904075)Phoenix Diagnostics, Inc.1990-12-06
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA (K904050)Philips Medical Systems (Cleveland), Inc.1990-12-05
HORIZON REGULAR ETCHING GEL (K904199)Horizon Chemical Co.1990-12-05
EYE PAD (K904896)Ulti-Med Intl., Inc.1990-12-05
RUBEOLA IGG ELISA TEST (K904854)Gull Laboratories, Inc.1990-12-04
P AND T MEDIUM (K904773)Gibson Laboratories, Inc.1990-12-04
ICOR HCH 4, ICOR HCH 7 (K904338)Icor AB1990-12-04
LATEX EXAMINATION GLOVES (K902796)Ek Hong Rubber Industry (Thailand) Co., Ltd.1990-12-04
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (K905086)Hpi, Inc.1990-12-03
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE (K900560)Acuson Corp.1990-12-03
KXO-80C/80D (K904043)Toshiba America Medical Systems, In.C1990-11-29
RUBBER LATEX SURGICAL GLOVES, STERILE (K905161)Rfb Latex Pvt. , Ltd.1990-11-29
FLOCARE (K904193)Flocare Medical1990-11-29
JAIN GRAFT ASSIST (K904536)Jain Surgical Equipment, Inc.1990-11-29
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE (K903358)Advance Medical Designs, Inc.1990-11-29
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT (K904184)Biotron U.S.A., Inc.1990-11-28
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 (K905096)Amresco, Inc.1990-11-28
MOTO-MED RF-II AND PICO (K893924)Holl Meditronics, Inc.1990-11-27
CARESS MASSAGER (K904915)Kendex Corp.1990-11-27
MUSCLE MASSAGER (K903617)Uri Halfon and Gabriel Hertzberg1990-11-26
INTRASITE GEL (LABELING REVISION) (K904411)Smith & Nephew United, Inc.1990-11-26
ACE/WILLIAMS MICROSURGERY SAW SYSTEM (K902525)Buckman Co., Inc.1990-11-26
MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES (K904950)Leander Research, Mfg & Distr., Inc.1990-11-26
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS (K904949)Micro-Aire Surgical Instruments, Inc.1990-11-26
ANGIOTEC IMAGE MANAGEMENT SYSTEM (K903806)Andros Analyzers, Inc.1990-11-23
HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE (K904526)Malaytex USA, Inc.1990-11-23
CANNULA, SURGICAL (K903416)Advantage Diagnostics Corp.1990-11-23
BIOCLUSIVE(R) ABSORBENT DRESSING (K896828)Johnson & Johnson International1990-11-21
DERMASORB WOUND CONTACT LAYER DRESSING (K903645)Convatec, A Division of E.R. Squibb & Sons1990-11-21
SITE DIAPHRAGM CASSETTE (K904186)Site Microsurgical Systems, Inc.1990-11-21
CODMAN COLLINS RADIOPARENT STERNAL BLADES (K904352)Codman & Shurtleff, Inc.1990-11-21
ACCUPLACE (TM) (K904172)Dlp, Inc.1990-11-21
ELASTOPLAST (K904500)Beiersdorf, Inc.1990-11-21
PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (K905109)Tactyl Technologies, Inc.1990-11-21
NONPRESCRIPTION SUNGLASSES (K904281)Jennie G. Sales Co., Inc.1990-11-21
SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN (K905094)Medical Fittings, Inc.1990-11-20
KETONE TEST A SANWA STANDARD (K903367)Ihara Medics U.S., Inc.1990-11-20
FREEVENT (TM) (K903057)Pharma Systems, Inc.1990-11-20
CIBA CORNING ACS FSH IMMUNOASSAY (K904649)Ciba Corning Diagnostics Corp.1990-11-20
KETONE TEST B SANWA STANDARD (K903366)Ihara Medics U.S., Inc.1990-11-20
SMART SCALE X-RAY PLATFORM (K904138)Olympic Medical Corp.1990-11-19
OPHTHASONIC A/P III (K903666)Teknar, Inc.1990-11-19
SLIMFLEX, PATIENT EXAMINATION GLOVES (K905033)Slim River Latex Sdn. Bhd.1990-11-19
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