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

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RecordFirmDate
GAUZE BANDAGE (K831284)Pac-Kit Safety Equipment Co.1983-08-12
SNO STRIPS STERILE TEARFLOW TEST STRIP (K832181)Smith & Nephew, Inc.1983-08-12
INSPETOSCOPE (K831614)Terayco Intl., Ltd.1983-08-12
HEARING AID UNITRON #UE8-D (K831883)Unitron Industries, Inc.1983-08-12
RIM-HAEMOPHILUS 1 & 2 (K832051)Austin Biological Laboratories1983-08-12
GAUZE SPONGE X-RAY DETECTABLE- (K832172)Sudreca Surgical Dressings, Inc.1983-08-12
PRP-1 REVERSED PHASE RESIN (K832197)Hamilton Co.1983-08-12
BANDAGE COMPRESS (K831282)Pac-Kit Safety Equipment Co.1983-08-12
GAUZE COMPRESS (K831281)Pac-Kit Safety Equipment Co.1983-08-12
AMERI CLEAR (K832011)Stephens Scientific1983-08-12
MAXI SHIELDS (K831593)Weyerhaeuser Co.1983-08-12
ELECTRIC INSTRUMENT TABLE (K832073)CooperVision, Inc.1983-08-12
HC40/HC75 PREPACKED COLUMS (K832198)Hamilton Co.1983-08-12
ALLERGENETICS FLUORO-FAST READER (K831870)Axonics, Inc.1983-08-12
GONOCHEK PANEL (K830756)E-Y Laboratories, Inc.1983-08-12
CEILING MOUNTED SUPPORT (K831086)Amsco Co.1983-08-12
READER MICROELISA SYSTEM (K831641)Organon Teknika Corp.1983-08-11
CMS 2000 SERIES TPN KITS (K831964)Currie Medical Specialties, Inc.1983-08-11
MERITEC-STREP GROUP A BETA-HEMOLYTIC (K831599)Meridian Diagnostics, Inc.1983-08-11
DENTAL ELECTRONIC/S.B.R TRADING BU HAND (K831824)Silverman'S1983-08-11
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS (K831924)Electro-Nucleonics Laboratories, Inc.1983-08-11
EMPTY DIALYSATE CONTAINER (K831689)Delmed, Inc.1983-08-11
AQUEOUS BLOOD GAS CONTROL LEVEL I,II & (K832003)American Dade1983-08-10
STAT-TRAK LIQUID ELECTROLYTE CONTROL (K831389)United Diagnostics, Inc.1983-08-10
DATA-ZYME URIC ACID PROCEDURE (K831983)Data Medical Associates, Inc.1983-08-08
MULTI-TITER DISPENSER (K832203)Hamilton Co.1983-08-08
BIOCHECK POSITIVE URINE CONTROL (K831994)Helena Laboratories1983-08-08
WASHER 6000 MICRO-C LISA SYSTEM (K831640)Organon Teknika Corp.1983-08-08
IMMULON SUBSTRATE REMOVAWELL STRIPS (K832117)Dynatech Corp.1983-08-08
NML-5010/5020 MULTI-DETECTOR SYSTEM (K832002)Nuclear Medical Laboratories, Inc.1983-08-08
PIPETTE 12 CHANNEL (K831644)Organon Teknika Corp.1983-08-01
SPLINT WOOD (K832144)Vermont Wood Industries, Inc.1983-08-01
AMBULIZER MODEL MC-5 (K832161)Mobilizer Medical Products, Inc.1983-08-01
PHONIC EAR PE 845PPC-D (K832081)Phonic Ear, Inc.1983-08-01
DICON GLAUCOMA DIAG. CENTER 2000 SERIES (K832142)CooperVision, Inc.1983-08-01
LKB 2164 MACRO-SPIN R CENTRIFUGE (K831942)Lkb Instruments, Inc.1983-07-29
EMBEDDING RING (K831922)Polymer Technology Corp.1983-07-29
LKB 2160 MIDISPIN CENTRIFUGE (K831947)Lkb Instruments, Inc.1983-07-29
DISPOSABLE MICROTOME BLADES (K831921)Polymer Technology Corp.1983-07-29
LKB 2161 MIDISPIN R CENTRIFUGE (K831948)Lkb Instruments, Inc.1983-07-29
DIA STRIPS SYSTEM (K831623)California Immuno Diagnostic, Inc.1983-07-28
REVOLUTION RADIAL IMMUNODIFFUSION PLATE (K831811)Calbiochem-Behring Corp.1983-07-28
SILCATH CENTRAL CATHETER TRAY W/18 GA (K831453)Argon Medical Corp.1983-07-28
SODIUM HYPOCHLORITE 3% (K831620)Omega Medical Diagnostics1983-07-28
MACLEAN-FOGG, DISP. BASE MOLD (K831900)Polymer Technology Corp.1983-07-28
PRO QUANTUM (K831249)Abbott Laboratories1983-07-28
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC (K831866)Varian Assoc., Inc.1983-07-28
TISSUE-TEK V.I.P. 100/200 (K831313)Miles Laboratories, Inc.1983-07-28
INTRA-ORAL ARTIFICIAL LARYNX (K831127)Xomed, Inc.1983-07-28
TRICYCLIC ANTIDEPRESSANTS (K831736)Utak Laboratories, Inc.1983-07-28
SODIUM HYPOCHLORITE 7% (K831619)Omega Medical Diagnostics1983-07-28
LYOPHILIZED MICROORGANISMS (K831653)Austin Biological Laboratories1983-07-28
MODIFIED SOYBEAN CASEIN DIGEST BROTH (K831671)Isle Media and Sterile Products, Inc.1983-07-28
SOLARCRYL CUSTOM TRAY MATERIAL (K831293)Solar Dental Co., Inc.1983-07-26
FR ROOT CANAL SEALER (K830764)Shizai Corp.1983-07-26
MAPROTILINE (K831735)Utak Laboratories, Inc.1983-07-26
EGG YOLK AGAR (K831827)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-07-26
AMOXAPINE 8-HYDRO-XYAMOXAPINE (K831734)Utak Laboratories, Inc.1983-07-26
MICROELISA COMP (K831658)Organon Teknika Corp.1983-07-26
CAFFINE TOXICOLOGY CONTROL (K831738)Utak Laboratories, Inc.1983-07-26
HEATING BLOCK MICROELISA SYSTEM (K831642)Organon Teknika Corp.1983-07-26
STRIPREADER MICROELISA SYSTEM (K831643)Organon Teknika Corp.1983-07-26
HEARING AID G3H & G3T (K832129)Widex Hearing Aid Co., Inc.1983-07-26
FLURAZEPAM TOXICOLOGY CONTROL (K831741)Utak Laboratories, Inc.1983-07-26
TRIGLYCERIDES REAGENT SET (K831858)Stanbio Laboratory1983-07-22
CHOLESTEROL-ENZYMATIC REAGENT SET (K831863)Stanbio Laboratory1983-07-22
URIC-ACID TEST ENZYMATIC COLORIMETRIC (K831864)Stanbio Laboratory1983-07-22
THE BLOOM STETHOSCOPE (K830796)Stethophonics, Inc.1983-07-19
DISPOSABLE SCALPELS (K831798)I M, Inc.1983-07-19
TRICYCLIC ANTIDEPRESSNATS VI (K831737)Utak Laboratories, Inc.1983-07-19
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO (K831979)Syva Co.1983-07-19
HEMOSTATS (K831797)I M, Inc.1983-07-19
COLOSTOMY BAG (K830841)C & D Colostomy Pad Corp.1983-07-19
BETA SCAN NORMAL CONTROL SOLUTION (K831523)Orange Medical Instruments, Inc.1983-07-19
MULTICHEM ENZYMATIC CHOLESTEROL SYS (K831700)Simmler, Inc.1983-07-19
MICRO-THIN SURGICAL GLOVE (K831565)Ansell, Inc.1983-07-19
DISPOSABLE HEMOSTAT (STRAIGHT&CURVED (K831662)Medcare Products1983-07-19
TEST FOR HUMAN ALPHA ONE ACID GLYCO- (K831960)Kent Laboratories, Inc.1983-07-19
SCOLIMETER (K831898)Dr. Micheal A. Sabia1983-07-19
FLOW-CALIBRATION MODULE (K831758)The Perkin-Elmer Corp.1983-07-19
QUANTIMUNE HFSH RIA HUMAN FOLLICLE- (K831742)Bio-Rad1983-07-18
SPINAL FLUID TOTAL PROTEIN CONTROL (K831527)Quantimetrix Corp.1983-07-18
NEPHROLYTE (K831502)Flaitron Laboratories, Inc.1983-07-18
CERTAIN HB CO-OXIMETER CONTROL (K832028)Corning Medical & Scientific1983-07-18
WAKO CHOLESTEROL CII (K831687)Wako Chemicals USA, Inc.1983-07-18
INFANT EVALUATION CARRIER (K831731)E.M. Adams1983-07-18
WAKO R-GTP C-TEST (K831639)Wako Chemicals USA, Inc.1983-07-18
GENERAL SURGICAL INSTRUMENTS (K831805)Aim Corp.1983-07-14
PERSONAL AMPLIFIER MODULE (K830790)Electone, Inc.1983-07-12
LACIMAL INTUBATION SETS (K831901)Visitec Co.1983-07-12
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 (K831392)Travenol Laboratories, S.A.1983-07-12
LAMOREUX-OSI ELECTROGONIOMETER (K831040)Orthopedic Systems, Inc.1983-07-12
ENDODONTIC BROACH(76EKN) BARBED BROACH (K831749)Union Branch1983-07-12
DISPOSABLE CYSTOTOME (K831916)CooperVision, Inc.1983-07-12
OCULAR IRRIGATING CANNULA (K831532)Dey Laboratories, Inc.1983-07-12
COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG (K831888)Portable Travtion Device Co.1983-07-12
ORTHOPEDIC SURGICAL GLOVE (K831564)Ansell, Inc.1983-07-12
STRESS MACHINE (K831699)Dr. William F. Curran1983-07-12
SONIC MIST ULTRASONIC HUMIDIFIER (K831646)Douglas Products1983-07-12
ENDODONTIC ROOT CANAL PLUGGER FINGER- (K831748)Union Branch1983-07-12
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