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

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RecordFirmDate
ALCON SITE(R)-COMPATIBLE CASSETTE (K881682)Alcon Laboratories1988-07-01
SPECIFIC CHEMISTRY ANALYZER (K882081)The Rupp & Bowman Co.1988-07-01
BODAI M.D.D. ADAPTOR(TM) (K881849)B&B Medical Technologies, Inc.1988-07-01
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K (K881795)Shimadzu Precision Instruments, Inc.1988-07-01
UNI-PORT (K880543)Surgeon Surgical Instrumentation, Inc.1988-07-01
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT (K882343)Terumo Medical Corp.1988-07-01
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL (K881113)Creative Laboratory Products, Inc.1988-07-01
DSL SOMATOMEDIN-C (DSL #5600) (K875229)Diagnostic Systems Laboratories, Inc.1988-07-01
MINIFUGE, MODEL 70 (K882149)Utah Bioresearch, Inc.1988-07-01
SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (K881165)Sakura Finetek U.S.A., Inc.1988-07-01
HEMOGLOBIN SCREENING DEVICE (K882101)Portable Medical Laboratories, Inc.1988-07-01
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (K882495)Lakewood Biochemical Co., Inc.1988-07-01
MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 (K882323)Meicor, Inc.1988-06-30
MASK, GAS, ANESTHETIC (K882434)Eastmed Enterprises, Inc.1988-06-30
INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (K882346)Nordbye, Milchman, Barlage1988-06-30
ASTROSCAN 2100 MICROTITER PLATE READER (K881458)Astroscan , Ltd.1988-06-29
MSI 3003 SERIES BED (K881964)Med Service, Inc.1988-06-28
ULTRAVIOLET LIGHT PROTECTVE EYEWERE (K880666)Free Sun Intl. AB1988-06-28
HR-1000 W/SUFFIXES (B,C OR D) (K882184)Eigen1988-06-28
JAYCO HYDROGEN MONITOR (K882499)Enteron, Inc.1988-06-28
3M WOUND CONTACT MATERIAL, PRODUCT #563X (K881988)3M Company1988-06-27
STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT (K882253)Stoute'S "Assist-Seat" Corp.1988-06-27
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (K881358)Neuroscientific Corp.1988-06-27
DELFIA ESTRADIOL KIT (K882173)Pharmacia, Inc.1988-06-24
HUMID-VENT FILTER (K881657)Gibeck Respiration1988-06-24
SUIT, SURGICAL (K882282)A Plus International, Inc.1988-06-23
SURGEONS CAP (K882284)A Plus International, Inc.1988-06-23
KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT (K880384)Kimberly-Clark Corp.1988-06-23
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT (K882244)Richards Medical Co., Inc.1988-06-23
THE DIRECTION DIAL (K882309)Lawhorn Innovations1988-06-23
COVER, SHOE OPERATING ROOM (K882280)A Plus International, Inc.1988-06-23
MALLET, SURGICAL (K882349)Treace Medical, Inc.1988-06-23
STORZ DIAGNOSTIC MICROSCOPE SYSTEM (K882269)Storz Instrument Co.1988-06-23
BOUFFANT CAP (K882283)A Plus International, Inc.1988-06-23
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (K882463)Lakewood Biochemical Co., Inc.1988-06-22
AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP. (K882135)Vita Dental Co.1988-06-22
2P-QDA FOOT PRESSURE SYSTEMS REAL TIME (K882139)Human Performance Technologies, Inc.1988-06-22
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL (K882277)Abbott Laboratories1988-06-22
AUTOMATIC CALORIC IRRIGATION SYSTEM (K881630)Ics Medical Corp.1988-06-21
MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES (K882210)Linde Div. Union Carbide Corp.1988-06-21
SAFETY DRAIN (K881790)Ballard Medical Products1988-06-21
DENTAL BURS (K882183)Tri-Stage, Inc.1988-06-21
ASEPTIP (K882399)Koppa Innovative Dental Products, Inc.1988-06-21
LYPHOCHEK URINE TOXICOLOGY CONTROL (K881989)Bio-Rad1988-06-20
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL (K880145)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K881991)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K881990)Bio-Rad1988-06-20
HEMO SUC NUMBER HS100-HS205 (K881036)Instrumental Medico Croquevielle S.A.1988-06-20
HELENA REP GEL PROCESSOR (K882163)Helena Laboratories1988-06-20
DUNFORD SURGEON'S STERILE GLOVES (K880480)Phillippine Radiant C/O U.S. Polymer Industries1988-06-17
SURGICAL DUCT CLAMP (VINE) (K882169)Henley Intl.1988-06-17
NEOTECH UNIVERSAL ADAPTER (K882203)Neotech Products, Inc.1988-06-17
PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (K881378)Pfizer, Inc.1988-06-17
MICRODISCECTOMY CURRETTES (K882077)Karlin Technology, Inc.1988-06-17
SPINAL DISTRACTORS, SPANNERS (K882069)Karlin Technology, Inc.1988-06-17
AT EASE STRESS PAD (K880454)Hospital Specialty Co.1988-06-16
SUCTION RETRACTORS (K882074)Karlin Technology, Inc.1988-06-16
SPINAL SURGERY FRAME (K882078)Karlin Technology, Inc.1988-06-16
B. CAT CONFIRM (K880694)Scott Laboratories, Inc.1988-06-16
MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (K882357)Stat Path1988-06-16
SELF-RETAINING SOFT TISSUE RETRACTOR (K882075)Karlin Technology, Inc.1988-06-16
HUMID-VENT 2 S FLEX (K881656)Gibeck Respiration1988-06-16
VITEK YEAST BIOCHEMICAL CARD (K881925)Vitek Systems, Inc.1988-06-16
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 (K882128)Tecnol New Jersey Wound Care, Inc.1988-06-15
MURSE RETRACTOR (K882112)Euro-American Marketing Group, Inc.1988-06-15
SOFT TISSUE BIOPSY DEVICE (K882013)Ocean Medical Products, Ltd.1988-06-15
SURGICAL INSTRUMENTS (K881937)Far East Intl. Trading Corp.1988-06-15
ZINC FORMALIN CONCENTRATE (K882268)Anatech, Ltd.1988-06-15
EASY WASHER II MICROPLATE WASHER (K881797)Slt Labinstruments, Inc.1988-06-15
JEDMED MICRO CCD CAMERA SYSTEM (K882166)Jedmed Instrument Co.1988-06-15
EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 (K881449)Baxter Healthcare Corp1988-06-15
SURGICAL BLADE (K881638)Far East Intl. Trading Corp.1988-06-15
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K881898)Atlantic Antibodies1988-06-14
SANAPLAST (K881397)Nebo Industries1988-06-14
MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER (K882063)Zest Anchors, Inc.1988-06-13
COBAS EIA(TM) PHOTOMETER (K881877)Roche Diagnostic Systems, Inc.1988-06-10
HDL CHOLESTEROL KIT (K881244)Trace Scientific , Ltd.1988-06-10
FLOSS CARD (K882164)Arthur Blank & Co., Inc.1988-06-10
OXY-CATH (K881428)Pulmonary Medical Devices, Inc.1988-06-10
ACE SCREW REMOVAL TREPHINE (K882008)Buckman Co., Inc.1988-06-10
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (K864159)Chem-Elec, Inc.1988-06-10
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET (K881773)Casco Standards1988-06-10
HUMID-VENT 2 S (K881644)Gibeck Respiration1988-06-10
IQ HDL CHOLESTEROL (K881891)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-06-10
LIFESTAT 1600 PRINTER (K881346)Physio-Control Corp.1988-06-09
SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670)Molecular Biosystems, Inc.1988-06-08
RID PLATE READER (K881174)The Binding Site, Ltd.1988-06-08
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM (K881774)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-06-08
TEMPA-DOT CLINICAL THERMOMETER SHEATH (K881286)Pymah Corp.1988-06-08
DRY COMFORT DISPOSABLE UNDERPAD (K881969)Health Tec, Inc.1988-06-07
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY (K881617)Granbio, Inc.1988-06-07
DAHLBERG MODEL GP BODY AID (K881417)Dahlberg Electronics, Inc.1988-06-07
GENT-L-KARE VAGINAL IRRIGATION SET (K881216)Geneva Laboratories, Inc.1988-06-07
DYNATECH SPD 2000, NUMBER 002-910-0000 (K881195)Dynatech Laboratories, Inc.1988-06-07
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (K882182)Lakewood Biochemical Co., Inc.1988-06-06
STUART LEE CLIP (K881741)Stuart-Lee, Inc.1988-06-03
DRIPRIDE DISPOSABLE UNDERPAD (K881859)Weyerhaeuser Co.1988-06-03
MSI 2005 SERIES BED (K881962)Med Service, Inc.1988-06-03
VITALOGRAPH-EC60 HYDROGEN MONITOR (K874892)Vitalograph , Ltd.1988-06-02
DIAMOND'S MEDIUM MODIFIED (K881995)Remel Co.1988-06-02
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