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

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RecordFirmDate
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS (K844634)Precision Dynamics Corp.1985-01-30
BIO-STAT III PLATE WASHER (K844552)Whittaker Bioproducts, Inc.1985-01-30
POLYSTAT, BIOLOGICAL STAIN (K844640)Surgipath Medical Industries, Inc.1985-01-30
JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR (K844093)Jcm Labs, Inc.1985-01-29
STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 (K845023)Storz Instrument Co.1985-01-28
SYSTE MATE IRON, HEM NO. 67224 (K845020)Em Diagnostic Systems, Inc.1985-01-28
THE BIBICURE SYS BREAST TONER (K843544)Les Entreprises Bibi, Inc.1985-01-25
GORE-TEX TUNNELER (K844584)W. L. Gore & Associates, Inc.1985-01-24
AIRCO NITROUS OXIDE REGULATOR (K850106)Airco, Inc.1985-01-24
OMNIMED NASAL OXYGEN CANNULA (K850066)Omni Intl., Inc.1985-01-24
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (K844120)Echo Ultrasound1985-01-23
IN THE EAR MODEL X-ITE 84 (K844985)Bernafon, Inc.1985-01-23
ADVANCED HEARING INSTRUMENTS - HEARING AIDS (K844728)Advanced Hearing Instruments1985-01-23
HEARING AID, UNITRON UE12-PPL (K843246)Unitron Industries, Inc.1985-01-23
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (K844247)Technicare Corp.1985-01-23
DR. HESSEL'S INSECT POISON REMOVER (K844048)Medie Group1985-01-23
SKIN STAT II SKIN STAPLING MEDICAL DEVICE (K844838)Edward Weck, Inc.1985-01-23
PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS (K844176)Premie Comfort Products1985-01-23
HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE (K850014)Medi-Dent American, Inc.1985-01-23
VISISTAT SKIN STAPLING DEVICE (K844837)Edward Weck, Inc.1985-01-23
MECON X (TEN) (K843484)Mecon Labs1985-01-23
SONOCARE (K844034)Echo Ultrasound1985-01-23
TITERTEK MICROPLATE WASHER 120 (K844500)Flow Laboratories, Inc.1985-01-22
TITMUS VISION TESTER II (K844694)Titmus Optical, Inc.1985-01-22
MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER (K844132)Sigma Teleproducts, Inc.1985-01-22
FORCEPS & HAMOSTATS (K844062)I M, Inc.1985-01-18
TDX TOTAL ESTRIOL (K844511)Abbott Laboratories1985-01-18
PRE-KLENE ENAMEL CLEANER (K844572)Medical Products Laboratories, Inc.1985-01-18
SURGICAL SCALPEL BLADES & DISPOSABLES (K844759)Cross Country Paper Products Corp.1985-01-18
CLINIFACTS 10 DATA MANAGEMENT SYSTEM (K844907)Miles Laboratories, Inc.1985-01-18
EMIT IMIPRAMINE/DESIPRAMINE CONTROL (K844945)Syva Co.1985-01-18
STERILE SALINE SOLUTION (K843797)Paco Pharmaceutical Services, Inc.1985-01-18
UNITED SKIN BARRIERS (K844938)Pfizer, Inc.1985-01-18
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K845027)Eastman Kodak Company1985-01-18
COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH (K844066)Clinetics Corp.1985-01-18
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL (K844946)Syva Co.1985-01-18
ROCHE REAGENTS REAGENT FOR URIC ACID (K844986)Roche Diagnostic Systems, Inc.1985-01-18
UNITED SKIN BARRIER PASTE (K844341)Howmedica Corp.1985-01-18
TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (K844547)bioMerieux, Inc.1985-01-16
SCENTED MENSTRUAL PAD (K844602)Procter & Gamble Mfg. Co.1985-01-16
CYSTINE TRYPTIC AGAR W/DEXTROSE (K844542)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/LACTOSE (K844543)bioMerieux, Inc.1985-01-16
UREA AGAR (K844548)bioMerieux, Inc.1985-01-16
VENTRESCREEN STREP A TEST (K844855)Ventrex Laboratories, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/MALTOSE (K844544)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/SUCROSE (K844546)bioMerieux, Inc.1985-01-16
BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY (K844625)Bipore, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/MANNITOL (K844545)bioMerieux, Inc.1985-01-16
UNSCENTED MENSTRUAL PAD (K844601)Procter & Gamble Mfg. Co.1985-01-16
SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST (K844582)Syncor Intl. Corp.1985-01-16
CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (K845010)Chesebrough-Pond'S U.S.A. Co.1985-01-15
CONTINENT STOMA SYSTEM & ACCESSORIES (K844186)Chesebrough-Pond'S U.S.A. Co.1985-01-15
SECURLINE SURGICAL SKIN MARKER 1000 (K844865)Precision Dynamics Corp.1985-01-14
ESOPHAGEAL STETHOSCOPE (K844444)Medical Parameters, Inc.1985-01-10
SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT (K844342)Personal Products Co.1985-01-10
CAPS (O.R. NURSE, SURGICAL) (K844704)Medicon, Inc.1985-01-10
L100D PATIENT CIRCUIT DUAL LINE (K844290)Life Products, Inc.1985-01-10
GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (K844613)Packaging Technologies, Inc.1985-01-10
HEARING AID, UNITRON UE12-PP (K843245)Unitron Industries, Inc.1985-01-10
SHOE COVERS (K844705)Medicon, Inc.1985-01-10
ABSORBENT ENDODONTIC POINT (K843017)United Dental Mfg., Inc.1985-01-09
MINI FLOW- DENTAL FLOSS (K844626)Mini Floss1985-01-09
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN (K844125)Bio-Rad1985-01-08
UROCYSTIN (K843382)Mission Pharmacal Co.1985-01-08
ALT/GPT REAGENT SET (K844251)Sterling Biochemical, Inc.1985-01-08
RESPIRALEX LATEX AGGLUTINATION TEST (K844399)Orion Diagnostica, Inc.1985-01-08
DERMIDRESS (K844463)Kells Medical, Inc.1985-01-08
CELL-MATICS HERPES SIMPLEX VIRUS DETECT (K840366)Difco Laboratories, Inc.1985-01-08
INNOFLUOR PRIMIDONE (K844721)Innotron Diagnostics1985-01-08
COLOPLAST URO 2002 UROSTOMY SYSTEM (K844685)Coloplast A/S1985-01-08
UROL-QUAL (K844760)Dimension Diagnostics1985-01-08
DATA-CHEM MAGNESIUM (K844278)Data Medical Associates, Inc.1985-01-08
COOKED MEAT MEDIUM (K844538)bioMerieux, Inc.1985-01-07
V AGAR (K844513)bioMerieux, Inc.1985-01-07
BEHIND THE EAR HEARING AID BERNAFON T-88P (K844621)Bernafon, Inc.1985-01-07
DTM AGAR (K844514)bioMerieux, Inc.1985-01-07
SELENITE BROTH (K844527)bioMerieux, Inc.1985-01-07
TRYPTIC SOY BROTH (K844541)bioMerieux, Inc.1985-01-07
VIOLET RED BILE AGAR (K844515)bioMerieux, Inc.1985-01-07
SIM MEDIUM (K844521)bioMerieux, Inc.1985-01-07
EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (K844710)Logos Scientific, Inc.1985-01-07
PHENOL RED BROTH W/CARBOHYDRATES (K844539)bioMerieux, Inc.1985-01-07
NUTRIENT BROTH (K844528)bioMerieux, Inc.1985-01-07
TRICHOMONAS BROTH (K844533)bioMerieux, Inc.1985-01-07
GN BROTH (K844524)bioMerieux, Inc.1985-01-07
BRAIN HEART INFUSION BROTH (K844529)bioMerieux, Inc.1985-01-07
HAEMOPHILUS I.D. QUAD (K844519)bioMerieux, Inc.1985-01-07
SIMMONS CITRATE AGAR (K844532)bioMerieux, Inc.1985-01-07
COLUMBIA CNA AGAR W/5% SHEEP BLOOD (K844517)bioMerieux, Inc.1985-01-07
MODEL 363C HEARING AID (K844648)Telex Communications, Inc.1985-01-07
EPPENDORF DILUTER (K844798)Medical Technomics, Ltd.1985-01-07
BRAIN HEART INFUSION W/6.5% SODIUM CHLORIDE (K844530)bioMerieux, Inc.1985-01-07
THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR (K844526)bioMerieux, Inc.1985-01-07
CYSTINE TRYPTIC AGAR W/FRUCTOSE (K844540)bioMerieux, Inc.1985-01-07
TRIPLE SUGAR IRON (K844531)bioMerieux, Inc.1985-01-07
STREPTOCOCCUS SELECTIVE AGAR (K844518)bioMerieux, Inc.1985-01-07
SELENITE CYSTINE BROTH (K844525)bioMerieux, Inc.1985-01-07
FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR (K844537)bioMerieux, Inc.1985-01-07
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE (K844655)Boehringer Mannheim Corp.1985-01-07
CAMPYLOBACTER CVA AGAR (K844534)bioMerieux, Inc.1985-01-07
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