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

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RecordFirmDate
REUSEABLE BREATHING TUBES (K873927)Dryden Corp.1987-10-20
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (K873431)Serono Diagnostics, Inc.1987-10-20
GENERAL PURPOSE COMBINATION PH ELECTRODE (K871921)Chemfet Corp.1987-10-20
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (K874054)Fisher Scientific Co., LLC1987-10-20
OSMOMETER MODEL 110 (K873642)Advanced Instruments, Inc.1987-10-20
INTERNATIONAL MODEL XL BEHIND-THE-EAR (K873799)Int'L Hearing Aids, Inc.1987-10-20
A-QC CLINICAL CHEMISTRY CONTROL (K873611)Arden Medical Systems, Inc.1987-10-20
ALBUMIN SCREEN TEST (K870516)Sclavo, Inc.1987-10-20
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (K873868)Unipath , Ltd.1987-10-20
URIC ACID PAP (K873363)Boehringer Mannheim Corp.1987-10-19
GEMSTAR II SYSTEM (K873617)Electro-Nucleonics Laboratories, Inc.1987-10-19
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER (K873749)Ciba Corning Diagnostics Corp.1987-10-19
EDI 320 (K873599)Cybex1987-10-16
YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN (K872700)Sita, Inc.1987-10-15
STANDARD KNIFE, DISPOSABLE #TM-1610 (K873712)Arthropedics, Inc.1987-10-15
INTRA-ARTICULAR ARTHROSCOPIC SHAVER (K874044)Medline Industries, Inc.1987-10-15
ACROMED BONE PLATE BENDER (K872949)Buckman Co., Inc.1987-10-15
IDENTICULT-BL (K873509)Scott Laboratories, Inc.1987-10-15
WILLIAMS VERTEBRAL SPREADER (K872858)Ace Medical Co.1987-10-15
STOMACH EVACULATOR - EWALD STYLE (K864963)Medovations, Inc.1987-10-14
USI DENTAL POLISHER. A/G-20 (K873147)Cranston Ind., Inc.1987-10-14
U-IMPULSE TVC AIR CONDUCTION HEARING AID (K873559)Richards Medical Co., Inc.1987-10-14
HUFFMAN BIOPSY UNIT (K873176)Penn Medical Devices, Inc.1987-10-14
INSPIREASE(R), DRUG DELIVERY SYSTEM (K873793)Key Pharmaceuticals, Inc.1987-10-13
APOLIPOPROTEIN B (K873864)Unipath , Ltd.1987-10-13
APOLIPOPROTEIN A1 (K873863)Unipath , Ltd.1987-10-13
ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (K871526)Cox Family Laboratories, Inc.1987-10-13
IMSI/EASY FLOAT MATTRESS (K872876)Intl. Management Services, Inc.1987-10-13
ISTAT SOFTWARE (K871931)Neuroscience, Inc.1987-10-13
TRACH CARE START KIT (K873732)Ballard Medical Products1987-10-13
SAFEWEIGH MAGIC SCALE (K872524)Health Care Innovations, Inc.1987-10-09
ORTHODONTIC ARCH (K872622)Wonder Wire1987-10-09
INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) (K873477)Vortran Medical Technology 1, Inc.1987-10-09
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT (K873355)Medix Biotech, Inc.1987-10-09
MULTI-ACCESS REAGENT DISPENSER (K873416)Electro-Nucleonics Laboratories, Inc.1987-10-09
CONFORMA(TM) PLASTER BANDAGES (K873111)The Kendal Co.1987-10-09
TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033 (K873482)Lakewood Biochemical Co., Inc.1987-10-08
TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023 (K873480)Lakewood Biochemical Co., Inc.1987-10-08
COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206 (K873479)Lakewood Biochemical Co., Inc.1987-10-08
MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C) (K873827)Lakewood Biochemical Co., Inc.1987-10-08
TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020 (K873483)Lakewood Biochemical Co., Inc.1987-10-08
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 (K873481)Lakewood Biochemical Co., Inc.1987-10-08
ACA URINE DRUGS OF ABUSE CONTROL (K873539)E.I. Dupont DE Nemours & Co., Inc.1987-10-07
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT (K873668)Medix Biotech, Inc.1987-10-07
GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038 (K873412)Lakewood Biochemical Co., Inc.1987-10-06
VOCALTECH VOCAL FEEDBACK DEVICE (K871590)Vocaltech C/O Hogan & Hartson1987-10-06
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990 (K873828)Lakewood Biochemical Co., Inc.1987-10-06
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR (K873413)Lakewood Biochemical Co., Inc.1987-10-06
FIAX TEST KIT FOR MUMPS-G ANTIBODIES (K872733)Whittaker Bioproducts, Inc.1987-10-06
SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 (K873411)Lakewood Biochemical Co., Inc.1987-10-06
AR DIACOAT SINGLE VISION LENSES (K873245)Seiko Optical Products of America, Inc.1987-10-05
INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 (K872607)Randolph Engineering, Inc.1987-10-05
FLEX GOLD (K873649)Flexmedics1987-10-05
CAST CUTTER, 115V MODEL NO. 4183-106 (K873719)Martin Medical1987-10-02
PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 (K873722)Martin Medical1987-10-02
CAST CUTTER, 230V MODEL NO. 4183-107 (K873720)Martin Medical1987-10-02
SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (K873324)Lakewood Biochemical Co., Inc.1987-10-02
TITAN GEL HDL CHOLESTEROL KIT (K873547)Helena Laboratories1987-10-02
MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 (K873704)Lakewood Biochemical Co., Inc.1987-10-02
ANSWER OVULATION TEST KIT (K871241)Armkel, LLC1987-10-02
LYSINE IRON AGAR (LIA) PRODUCT #T3046 (K873703)Lakewood Biochemical Co., Inc.1987-10-02
CHILD WALKING HEEL PRODUCT NO. 4183-132 (K873718)Martin Medical1987-10-02
WINK-EASE PERSONAL PROTECTIVE EYEWEAR (K873662)Eye Pro Medical Products, Inc.1987-10-02
SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080 (K873326)Lakewood Biochemical Co., Inc.1987-10-02
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL (K873037)Diagnostic Products Corp.1987-10-02
LEUCOPREP BRAND TUBE (K872775)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-02
SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330 (K873327)Lakewood Biochemical Co., Inc.1987-10-02
SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE (K873325)Lakewood Biochemical Co., Inc.1987-10-02
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330 (K873329)Lakewood Biochemical Co., Inc.1987-10-02
SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252 (K873328)Lakewood Biochemical Co., Inc.1987-10-02
CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 (K873717)Martin Medical1987-10-02
SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412 (K873323)Lakewood Biochemical Co., Inc.1987-10-02
SURE-STREP A TEST KIT CATALOG NO. MB-1083 (K872346)Medix Biotech, Inc.1987-09-30
NONPRESCRIPTION SUNGLASSES (K873685)Arcotoys, Inc.1987-09-30
LEUKOCLIP(R) (K873744)Beiersdorf, Inc.1987-09-30
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (K873186)Serono Diagnostics, Inc.1987-09-29
SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD (K873320)Lakewood Biochemical Co., Inc.1987-09-29
U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID (K873560)Richards Medical Co., Inc.1987-09-29
SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL (K873318)Lakewood Biochemical Co., Inc.1987-09-29
QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (K873467)Quantimetrix Medical Industries1987-09-29
QTEST STREP (K872961)Quidel Corp.1987-09-29
SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 (K873321)Lakewood Biochemical Co., Inc.1987-09-29
TELSTAR MODEL PP (K873210)Telstar Electronics, Inc.1987-09-29
TIF FECAL TEST (K873594)Devetec, Inc.1987-09-29
SPECTROPHOTOMETER (MICROASSAY PLATE READERS) (K873678)Slt Labinstruments, Inc.1987-09-29
CUSTOM IN-THE-EAR HEARING AID SERIES MCA20 (K873468)Maico Hearing Instruments, Inc.1987-09-29
SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088 (K873322)Lakewood Biochemical Co., Inc.1987-09-29
MICRO-CHEM ANALYZER (K873638)Ocean Scientific, Inc.1987-09-29
SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE (K873319)Lakewood Biochemical Co., Inc.1987-09-29
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (K873400)Serono Diagnostics, Inc.1987-09-25
VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: (K871369)Keeler Instruments, Inc.1987-09-24
NINJA SCALPEL (K873493)Primrose Medical, Inc.1987-09-24
LACERATION AND INSTRUMENT TRAYS (K873290)Advantage Medical Systems, Inc.1987-09-24
SKYTRON MODEL 130 SURGICAL TABLE (K873478)Skytron, Div. the Kmw Group, Inc.1987-09-24
BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772 (K873224)Lakewood Biochemical Co., Inc.1987-09-23
MANNITOL SALT AGAR (MSA) PRODUCT #P1706 (K873227)Lakewood Biochemical Co., Inc.1987-09-23
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT (K872794)Medix Biotech, Inc.1987-09-23
MACCONKEY AGAR - PRODUCT #P1606 (K873223)Lakewood Biochemical Co., Inc.1987-09-23
EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309 (K873225)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409 (K873221)Lakewood Biochemical Co., Inc.1987-09-23
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