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

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RecordFirmDate
SYVA SOLID PHASE COLUMNS SYSTEM II (K861392)Syva Co.1986-06-13
JEDMED MINI-MOS VIDEO CAMERA (K862145)Jedmed Instrument Co.1986-06-13
HISTOLOGY PARAFFIN (K862141)Erie Scientific Co.1986-06-13
AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET (K861968)American Research Products Co.1986-06-13
INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH (K854765)C&C Systems, Inc.1986-06-13
LEE-BEAD PROLACTIN (EIA) (K861945)Leeco Diagnostics, Inc.1986-06-13
NEUROMETER (K853608)Neurotron, Inc.1986-06-12
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM (K861700)E.I. Dupont DE Nemours & Co., Inc.1986-06-11
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (K861997)Hazleton Research Products, Inc.1986-06-10
ERBIUM X-RAY FILTER (K860760)Reactor Experiments, Inc.1986-06-10
WEIGHTED ACQUISITION MODULE (K861637)Siemens Gammasonics, Inc.1986-06-10
SLIDE CULTURE U 'EIKEN' (K861631)Syn-Kit, Inc.1986-06-10
SUCTION SYSTEM (K861306)Axiom Medical, Inc.1986-06-09
POLYPOLE (K861838)Poly Medical Technologies, Inc.1986-06-09
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) (K861684)Seiko Optical Products of America, Inc.1986-06-09
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) (K861162)Efop1986-06-09
SAPPHIRE KNIFE BLADE (K861744)Keeler Instruments, Inc.1986-06-09
KOTEX PROFILE SHAPED MAXI PAD (K861902)Kimberly-Clark Corp.1986-06-09
DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM (K861996)Hazleton Research Products, Inc.1986-06-09
ZIMLITE LENS (K861960)Asahi Optical Co. C/O Rosati Associates, P.C.1986-06-09
SALIVA EJECTOR (K861934)Carlisle Laboratories, Inc.1986-06-09
JEDMED CCD-02 VIDEO CAMERA SYSTEM (K862034)Jedmed Instrument Co.1986-06-09
GIRARD SUNGLASSES (NON-PRESCRIPTION) (K861759)H. Girard S.A.1986-06-09
CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE (K861825)Storz Instrument Co.1986-06-09
PARALLEL ACTION PLIERS (K861953)Med-Tool, Inc.1986-06-06
VENTREX APO B (K861919)Ventrex Laboratories, Inc.1986-06-06
SURGICAL KNIFE (K861947)Sharpoint, Inc.1986-06-06
RX-33S INTRA MINI CANAL MODULE (K861532)Rexton, Inc.1986-06-05
TITERTEK MICROPLATE WASHER S-12 (K862066)Flow Laboratories, Inc.1986-06-05
SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (K862042)Associated Mills, Inc.1986-06-05
POLO DENTAL UNIT (K854647)Alpine Dental Equipment Co.1986-06-05
E. T. TAPE ENDOTRACHEAL TUBE HOLDER (K862084)B&B Medical Technologies, Inc.1986-06-05
APLICARE SKIN PROTECTANT SWABSTICK (K861558)Aplicare, Inc.1986-06-04
DIRECTATEX STREP A (K861575)Pacific Biotech, Inc.1986-06-03
D'ALA RAPID TEST (K861889)Pro-Lab, Inc.1986-06-03
100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (K861890)Richard-Allan Medical Ind., Inc.1986-06-03
HIPPURATE HYDROLYSIS TEST (K861888)Pro-Lab, Inc.1986-06-03
BEHING-THE-EAR HEARING AID SERIES SP (K861597)Maico Hearing Instruments, Inc.1986-06-02
RUBY & SAPPHIRE BLADE HOLDER (K861748)Keeler Instruments, Inc.1986-06-02
ROHO HEEL PAD (K861327)Roho, Inc.1986-06-02
SURGICAL PACKS, KITS AND TRAYS (K861530)Medical Concepts Development, Inc.1986-05-30
NEUTRALON SURGICAL GLOVES (K861441)Surgikos, Inc.1986-05-30
SURGICAL HEAD SUPPORT (K861915)Treace Medical, Inc.1986-05-30
BYRON WORD BARTHOLIAN GLAND CATHETER (K861877)Byron Medical1986-05-30
CRANIO BLADES AND WIRE PASS DRILL (K861876)New England Surgical Instrument Corp.1986-05-30
MEM GLASGOW POWDERED MEDIUM (K861887)Hazleton Research Products, Inc.1986-05-29
RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER (K861875)Hazleton Research Products, Inc.1986-05-29
ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM (K861872)Hazleton Research Products, Inc.1986-05-29
GENTAMICIN-50MG/ML (K861869)Hazleton Research Products, Inc.1986-05-29
IRON PROCEDURE (K861652)Data Medical Associates, Inc.1986-05-29
DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM (K861886)Hazleton Research Products, Inc.1986-05-29
MEM GLASGOW MEDIUM (K861873)Hazleton Research Products, Inc.1986-05-29
MEM ALPHA EAGLE MEDIUM (K861867)Hazleton Research Products, Inc.1986-05-29
CNS 4/8 AND CT 48.1 SOFTWARE (K860829)Cns, Inc.1986-05-29
DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER (K861870)Hazleton Research Products, Inc.1986-05-29
NCTC 109 MEDIUM (K861871)Hazleton Research Products, Inc.1986-05-29
WILLIAMS MEDIUM E (K861868)Hazleton Research Products, Inc.1986-05-29
TRYPSIN RIA KIT (K861097)Microanalytic Research, Inc.1986-05-29
MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER (K861874)Hazleton Research Products, Inc.1986-05-29
WILLIAMS MEDIUM E POWDER (K861885)Hazleton Research Products, Inc.1986-05-29
ALT/GPT PROCEDURE (K861658)Data Medical Associates, Inc.1986-05-29
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III (K860906)American Dade1986-05-29
GAMMA GLUTAMYL TRANSFERASE PROCEDURE (K861672)Data Medical Associates, Inc.1986-05-29
ROPHAE DIAMOND KNIFE (K861491)Rophae Lens Co., Inc.1986-05-28
ELASTIC LENS INJECTOR TM (K861085)Staar Surgical Co.1986-05-28
IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES (K861545)Rophae Lens Co., Inc.1986-05-28
STORZ E9050 & E9055 DIAMOND KNIVES (K861732)Storz Instrument Co.1986-05-28
MAGNESIUM PROCEDURE (K861668)Data Medical Associates, Inc.1986-05-27
THERACUSHION MODEL 1000 (K861834)General Physiotherapy, Inc.1986-05-27
RIONET HEARING AID (K861728)Rion Acoustic Instruments, Inc.1986-05-27
IRON PROCEDURE (K861603)Data Medical Associates, Inc.1986-05-23
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID (K860942)Quantimetrix Corp.1986-05-23
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE (K861749)Keeler Instruments, Inc.1986-05-23
MODUMATIC (R) DILUTER (K861640)Tri-Continent Scientific, Inc.1986-05-23
TOTAL IRON BINDING CAPACITY PROCEDURE (K861602)Data Medical Associates, Inc.1986-05-23
DIRECT READOUT MODULE ACCESSORY (K861412)E.I. Dupont DE Nemours & Co., Inc.1986-05-23
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 (K861512)Em Diagnostic Systems, Inc.1986-05-23
LIQUID CHROMATOGRAPHY COLUMNS (K861633)Supelco, Inc.1986-05-23
MEDCARE FORCEPS (THUMB, TISSUE) (K861805)Medcomp Technologies, Inc.1986-05-23
SHS CUSHION/WHEELCHAIR (K861755)Special Health Systems, Ltd.1986-05-23
THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS (K861751)Special Health Systems, Ltd.1986-05-23
CONTROL SERA LEVEL VALUES (MG/DL) (K861567)E.I. Dupont DE Nemours & Co., Inc.1986-05-23
MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) (K861807)Medcomp Technologies, Inc.1986-05-23
KINESETHETIC SEATING SYSTEM/WHEELCHAIR (K861754)Special Health Systems, Ltd.1986-05-23
THERACHEM-PLUS, TRI-LEVEL TDC (TM) (K861185)Fisher Scientific Co., LLC1986-05-23
BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) (K860720)Biotrack, Inc.1986-05-23
CHECK-UP PLAQUE FIGHTING GUM (K860843)Minnetonka, Inc.1986-05-21
ZEST MARK II (STANDARD & MINI) (K861561)Zest Anchors, Inc.1986-05-21
LASER SKIN MARKER AND MASK WHITE LOTION (K861772)Pacific Poly Crafts1986-05-21
CHICKEN SERUM - STERILE FILTERED (K861810)Hazleton Research Products, Inc.1986-05-20
HUMAN AB SERUM - STERILE FILTERED (K861813)Hazleton Research Products, Inc.1986-05-20
GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (K861824)Flow Laboratories, Inc.1986-05-20
HUMAN SERUM - STERILE FILTERED (K861812)Hazleton Research Products, Inc.1986-05-20
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (K861823)Flow Laboratories, Inc.1986-05-20
BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE (K861815)Hazleton Research Products, Inc.1986-05-20
MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE (K861816)Hazleton Research Products, Inc.1986-05-20
LAMB SERUM - STERILE FILTERED (K861809)Hazleton Research Products, Inc.1986-05-20
SENSITITRE AUTO ID PLATE, AP70 (K861058)Gibco Laboratories Life Technologies, Inc.1986-05-20
PENICILLIN-STREPTOMYCIN-FUNGIZONE (K861791)Flow Laboratories, Inc.1986-05-20
RHESUS MONKEY SERUM - STERILE FILTERED (K861814)Hazleton Research Products, Inc.1986-05-20
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