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

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RecordFirmDate
A-SORB (K882115)Howard Medical Co.1988-10-03
HARE COLD PACK (K883966)Dyna Industries, Inc.1988-09-30
URISCREEN (K882211)Diatech Diagnostica , Ltd.1988-09-30
DERMTRODE (K883869)World Precision Instruments, Inc.1988-09-30
#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY (K883593)Ecolab, Inc.1988-09-30
MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) (K883951)J R Scientific1988-09-30
MULTI-CARE CHAIR (K883309)Mid-Canada Medical1988-09-30
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (K883607)Codman & Shurtleff, Inc.1988-09-30
MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY (K883127)Advanced Mechanical Technology, Inc.1988-09-30
AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K883124)Amersham Corp.1988-09-30
DRY COMFORT UNDERGARMENT (K882418)Health Tec, Inc.1988-09-29
MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND (K883023)Mentor Corp.1988-09-29
LINDSTROM CORDLESS EPILATOR (K883429)A Place of Health & Beauty1988-09-28
MEC-1 VIDEO COMBO SYSTEM (K883944)Medical Concepts, Inc.1988-09-28
CCM-1 VIDEO CAMERA SYSTEM (K883943)Medical Concepts, Inc.1988-09-28
STORZ MODEL 62 ENT CAMERA SYSTEM (K883760)Storz Instrument Co.1988-09-28
PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP (K882981)Pioneering Technologies, Inc.1988-09-27
PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) (K883135)Pioneering Technologies, Inc.1988-09-26
CASF DRILL GUIDE DG 170 (K882871)Terray Manufacturing, Inc.1988-09-23
AREA (DENTAL CHAIR) (K880474)Alpine Dental Equipment Co.1988-09-23
SKEMA (DENTAL UNIT) (K880475)Alpine Dental Equipment Co.1988-09-23
QUIDEL PREGNANCY TEST CONTROL (K883316)Quidel Corp.1988-09-22
SPINAL MICROKNIFE (K882525)Karlin Technology, Inc.1988-09-22
QM300 PREALBUMIN ANTIBODY PACK (K883002)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS (K882678)Siemens Hearing Instruments, Inc.1988-09-22
PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. (K882654)Surgical Innovators of America, Inc.1988-09-20
HEART HUGGER STERNUM SUPPORT HARNESS (K882592)General Cardiac Technology, Inc.1988-09-20
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE (K883181)Beckman Instruments, Inc.1988-09-19
EXCELVIEW ILLUMINATOR (K883702)Excel Medical Products, Inc.1988-09-19
COULTER VISCOMETER II (K883503)Coulter Electronics, Inc.1988-09-19
A.C.I. TRACH TIE (K882891)Auxiliary Care, Inc.1988-09-19
EMIT (R) HVA NEGATIVE URINE (K883210)Syva Co.1988-09-19
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY (K883395)Quantimetrix Medical Industries1988-09-19
CHANG MEDIUM (ADDITIONAL INDICATIONS) (K883682)Hana Biologics, Inc.1988-09-16
PERFORMED CROWN (STAINLESS STEEL) (K883325)Whitecap Dental Co.1988-09-16
VITEK GRAM-NEGATIVE IDENTIFICATION CARD (K883558)Vitek Systems, Inc.1988-09-16
KOMET SURGICAL BUR (K883255)Komet Medical, Div. of Brasseler USA I, L.P.1988-09-15
OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (K883613)Stierlen-Maquet AG1988-09-15
VITRABOND LIGHT CURE GLASS IONOMER LINER (K882821)3M Company1988-09-15
SUNGLASSES, IMPORTED (K883771)Norcon, Inc.1988-09-15
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR (K882721)Hear-O Inc. C/O L.P. Leale & Assoc.1988-09-15
SKID RESISTANT, LONG LASTING SHOE COVERS (K883657)James River Corp.1988-09-15
PRL-QUANT (K883269)Leeco Diagnostics, Inc.1988-09-13
STRYKER PRESSURE MONITOR SYSTEM (K883485)Stryker Corp.1988-09-13
THORACIC CATHETERS (K883474)Westmark, Sterile Packing Systems, Inc. (Sps)1988-09-13
IQ HDL CHOLESTEROL (K883353)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-13
URIC ACID REAGENT (PRODUCT #88219) (K883404)Hichem Diagnostics1988-09-13
TRIGLYCERIDES REAGENT (PRODUCT #88218) (K883405)Hichem Diagnostics1988-09-13
TECHNICON RA-100(TM) SYSTEM (K883209)Technicon Instruments Corp.1988-09-13
OPMI CS (K883581)Carl Zeiss, Inc.1988-09-13
EMAX PRECISION MICROPLATE READER (K883302)Molecular Devices Corp.1988-09-13
BIOTROL URIC ACID ENZYMATIQUE TRINDER (K883428)Biotrol, USA, Inc.1988-09-13
WHEELS-OFF QUICK RELEASE AXLE SYSTEM (K883679)Rolcontrol Products, Co., Inc.1988-09-13
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL (K883247)Quantimetrix Medical Industries1988-09-13
S 21 INSTRUMENT STAND (K883578)Carl Zeiss, Inc.1988-09-13
RAYMAX 2100 MODELS 2130 & 2136 (K883431)Raymax Medical Corp.1988-09-12
COLLAGEN SHIELD (K882762)Chiron Ophthalmics1988-09-12
BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (K881049)Microline Pentax, Inc.1988-09-12
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE (K883575)Site Microsurgical Systems, Inc.1988-09-12
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 (K882506)Span-America Medical Systems, Inc.1988-09-09
PHASE II FSH KIT (K883279)Vitek Systems, Inc.1988-09-09
GESCO CATHETERIZATION TRAY (K882647)Gesco Intl., Inc.1988-09-09
A.QC CHEMISTRY CONTROL LEVEL 2 (K883012)Arden Medical Systems, Inc.1988-09-09
ALTLTS ALANINE AMINO TRANSFERASE ALT (K883205)Electro-Nucleonics, Inc.1988-09-09
STAT FAX(TM) (K882938)Awareness Technology, Inc.1988-09-09
DADE TDM CONTROL (K883190)Baxter Healthcare Corp1988-09-09
RADKOR SFC-21 (K881701)Radkor, Inc.1988-09-08
OLYMPUS REPLY CHEMISTRY ANALYZER (K882451)Olympus Corp.1988-09-08
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST (K883385)Los Alamos Diagnostics1988-09-07
TECHNICON DPA-1 APOLIPOPROTEIN B (K883491)Technicon Instruments Corp.1988-09-07
EX-CELL 301, CATALOG NO. 200-3651 (K883625)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3601 (K883624)J R Scientific1988-09-07
MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 (K883628)J R Scientific1988-09-07
MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 (K883627)J R Scientific1988-09-07
HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 (K883629)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG # 210-3579 (K883631)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3600 (K883623)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 210-3575 (K883632)J R Scientific1988-09-07
QLIA IMMUNOCHEMISTRY SYSTEM (K883349)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-07
EX-CELL 301, CATALOG NO. 210-3577 (K883626)J R Scientific1988-09-07
RPMI-1640 MEDIUM, CATALOG NO. 210-3525 (K883630)J R Scientific1988-09-07
SELDIX 325 TWO PULSE GENERATOR/CONTROL (K883154)Bay X-Ray, Inc.1988-09-06
DISPOSABLE ARACHNOID KNIFE (K882422)Microbio-Medics, Inc.1988-09-06
BOW & ARROW DRILL GUIDE (K882407)Instrument Makar, Inc.1988-09-06
RADKOR XG-325 (K881696)Radkor, Inc.1988-09-02
LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (K883599)Innovative Medical Systems, Inc.1988-09-02
RADKOR, XG-515 (K883081)Radkor, Inc.1988-09-02
LARYNGOSCOPE RIGID (K882433)Eastmed Enterprises, Inc.1988-09-02
PHADEBACT ETEC-LT TEST (K874288)Pharmacia, Inc.1988-09-02
AMBU TWIN PUMP - (MANUAL SUCTION PUMP) (K883433)Ambu, Inc.1988-09-02
GRID/RADIOGRAPHIC (K883527)Umi, Inc.1988-09-02
RFA-300 RAPID FLOW ANALYZER W/COMPUTER (K883020)Alpkem Corp.1988-09-02
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE (K880878)Philips Medical Systems (Cleveland), Inc.1988-09-01
HEARING AID, UNITRON MODEL VISTA 1000 (K883513)Unitron Industries, Inc.1988-09-01
AD-HEAL(TM) WOUND DRESSING (K881731)Nepera, Inc.1988-08-31
OPER-FILM-ADHESIVE MEMBRANE (K881936)Iberhospitex, S.A.1988-08-31
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) (K880884)Immuno Concepts, Inc.1988-08-30
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (K882687)Gull Laboratories, Inc.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (K880885)Immuno Concepts, Inc.1988-08-30
FLOSSIE (K883225)Richard G. Deniro1988-08-30
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