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

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RecordFirmDate
AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE (K943145)The Monticello Group, Inc.1996-04-29
DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL (K960815)Dumex Medical Surgical Products, Ltd.1996-04-29
CARBOMEDICS MITRAL ROTATOR (K960923)Carbomedics, Inc.1996-04-29
EBNA IGG EIA TEST SYSTEM (K951549)Immunoprobe, Inc.1996-04-29
NEO 2 LINE SUCTION SYSTEM (K960488)Alcove Medical, Inc.1996-04-26
MM 324 (K961076)Micro-Mega Societe Anonyme1996-04-26
PREPOWDERED LATEX EXAMINATION GLOVES (K955888)Pantai Utama Sdn. Bhd.1996-04-26
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561)Diagnostic Systems Laboratories, Inc.1996-04-26
COMFIT ORTHOPEDIC (K960407)Wembley Rubber Products (M) Sdn Bhd1996-04-26
COMFIT MICROPTIC (K960416)Wembley Rubber Products (M) Sdn Bhd1996-04-26
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (K961148)Difco Laboratories, Inc.1996-04-26
POWDERFREE LATEX EXAMINATION GLOVES (K955889)Pantai Utama Sdn. Bhd.1996-04-26
PLANCON MIRCOLAMELLAR KERATOME (K960395)Plancon Instruments1996-04-26
NIL LATEX POWDERFREE EXAMINATION GLOVES (K955341)Shangrila Latex Industries Pvt. , Ltd.1996-04-26
OPUS CK-MB & TOTAL CK CONTROLS (K960275)Behring Diagnostics, Inc.1996-04-25
ALT INCORPORATING DST (K961123)Trace Scientific , Ltd.1996-04-25
TACTYLON POWDER FREE EXAMINATION GLOVE (K955464)Tactyl Technologies, Inc.1996-04-25
SERUM VOLATILES CONTROL LEVEL 1 & 2 (K955691)Clinical Controls, Inc.1996-04-24
VISARD SUNGLASSES (K961117)Visard Srl1996-04-24
D & K SUNGLASSES (K960798)D&K Stores, Inc.1996-04-24
SUNGLASSES (K961128)Vision-Pro Industrial, Ltd.1996-04-24
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 (K955690)Clinical Controls, Inc.1996-04-24
TOTAL PROTEIN (URINE) (K951222)Randox Laboratories, Ltd.1996-04-24
OAKLEY, INC SUNGLASSES (K961268)Oakley, Inc.1996-04-24
SUNGLASSES (K961034)Kylie Enterprise Co. , Ltd.1996-04-24
MINICLINIC OVULATION PREDICTOR (K960233)Vanguard Biomedical Corp.1996-04-23
IMMUNOLOGY CONTROL (K960824)Medical Analysis Systems, Inc.1996-04-23
LIQUID CARDIAC MARKER 1,2,3 ASSAYED (K960246)Ciba Corning Diagnostics Corp.1996-04-23
EXACTECH STERILE MODULAR DRILL BIT (K960720)Exactech, Inc.1996-04-23
DSL ACTIVE NON-EXTRACTION IGF-I IRMA (K961172)Diagnostic Systems Laboratories, Inc.1996-04-23
LARES RESEARCH AS-1 LOWSPEED HANDPIECE (K961163)Lares Research, Inc.1996-04-23
OPUS T3 CONTROLS (K961206)Behring Diagnostics, Inc.1996-04-23
PULPDENT ENDOPREP II (K961089)Pulpdent Corp.1996-04-23
G.E. STERILE ANGIOGRAPHIC TRAY (K960139)GE Medical Systems1996-04-19
RUSCH OPTOSAFE (K960240)Rusch Intl.1996-04-19
AM 400 (K961084)Electone, Inc.1996-04-18
MOLLOY INTUBATING STYLETTE (K943104)Molloy Corp.1996-04-18
M. CAT BUTYRATE DISK (K960996)Hardy Diagnostics1996-04-18
IMMUNOCARD TOXIN A (K955859)Meridian Diagnostics, Inc.1996-04-18
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER (K960382)Eastman Kodak Company1996-04-17
GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES (K954967)Guthrie Medicare Products (Melaka) Sdn Bhd1996-04-15
CARBOMEDICS VALVE TESTER (K960169)Carbomedics, Inc.1996-04-15
G.E. STERILE CT BIOPSY TRAY (K960144)GE Medical Systems1996-04-15
CARDS Q.S. STREP A (K955108)Quidel Corp.1996-04-15
POWERS ANTI-BACTERIAL VALVE (K954471)Powers Dental & Medical Technology, Inc.1996-04-15
POWDER FREE TACTYLON SURGEONS GLOVE (K955419)Tactyl Technologies, Inc.1996-04-15
D.O.R.C. VFI/VFE SYSTEM (K954842)Dutch Ophthalmic USA, Inc.1996-04-15
RTI MEDICAL (K954567)Radiology Telenetwork Intl.1996-04-12
HEARING AID - AIR CONDUCTION (K960684)Resound Corp.1996-04-10
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 (K960680)Resound Corp.1996-04-10
FRANCO SORDELLI SUNGLASSES (K960950)Franco Sordelli & C. Snc1996-04-10
SUNGLASSES OR MULTIPLE (K960890)Outdoor Action Wear Specialties1996-04-10
US-HOLO SUNGLASSES (K961035)Mi Technologies, Inc.1996-04-10
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (K960143)GE Medical Systems1996-04-09
LAST IMAGE HOLD (K951942)Insight Systems1996-04-08
PHILIPS SITE VIEW WORKSTATION (K960809)Philips Medical Systems North America, Inc.1996-04-07
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC (K960804)Miracle-Ear, Inc.1996-04-05
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY (K953971)Trace America, Inc.1996-04-05
ACTIVE LH IRMA (K961109)Diagnostic Systems Laboratories, Inc.1996-04-05
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR (K960410)Perfect Ear1996-04-04
TIGERSCAN/TIGERVIEW (K955237)Tau Corp.1996-04-04
VIP VICTOR INTERACTIVE PROBE (K960245)Pro-Dentec1996-04-04
LIPID CONTROL (K960862)Medical Analysis Systems, Inc.1996-04-03
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (K960997)Starplex Scientific, Inc.1996-04-03
AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL) (K960935)Hearing Solutions, Inc.1996-04-03
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS (K960378)Actimed Laboratories, Inc.1996-04-03
ACE SYSTEM (K960853)Xomed, Inc.1996-04-03
SILGEL TOPICAL GEL SHEET (K960254)Rofil Medical USA, Inc.1996-04-02
CPR IRRIGATION TRAY (K960212)Custom Pack Reliability1996-04-01
EXPANDACELL INSTRUMENT WIPE (K960621)Shippert Medical Technologies Corp.1996-04-01
TRUE TRIGLYCERIDE (K960088)Diagnostic Chemicals , Ltd.1996-04-01
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY (K960456)Denver Biomaterials, Inc.1996-04-01
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM (K954691)Access Radiology Corp.1996-03-29
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY (K960274)Orgentec1996-03-29
ACTIVE CROSSLAPS ELISA (K960171)Diagnostic Systems Laboratories, Inc.1996-03-28
LYNX DPA DISPOSABLE PROPHY ANGLE (K960541)Mti Precision Products1996-03-28
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (K955831)Sherwood Medical Co.1996-03-28
STAR TITAN SERIES MOTORS & ATTACHMENTS (K960260)Dentalez Group1996-03-28
CPR URINE BAG (K960217)Custom Pack Reliability1996-03-28
STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES (K960507)Dentalez Group1996-03-28
CPR LAP SPONGES (K960236)Custom Pack Reliability1996-03-28
STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE (K960719)Dentalez Group1996-03-28
NEVOSCOPE (K954943)Nizar A. Mullani1996-03-27
SUPERSTAND 300 (K935123)Wuestec Medical, Inc.1996-03-27
A-DEC PERFORMER CONTROL UNIT (K960506)A-Dec, Inc.1996-03-25
900UDX URINE PATHOLOGY SYSTEM (K960054)Intl. Remote Imaging Systems1996-03-22
LONG LIFE RX-12 (K960295)Rexton, Inc.1996-03-22
DOCUMENT TDM ULTRA ASSAYED CONTROL (K960244)Casco Standards1996-03-22
RETINOL BINDING RID KIT (K955881)The Binding Site, Ltd.1996-03-22
BINAX STREP A TEST (K960712)Binax, Inc.1996-03-22
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER (K960426)Medical Components, Inc.1996-03-21
LXN FRUCTOSAMINE TEST (K955629)Lxn Corp.1996-03-20
SPACELINE FEEL 21 (K953865)J. Morita USA, Inc.1996-03-20
HALL MODULAR ACETABULAR REAMER SYSTEM (K960852)Linvatec Corp.1996-03-20
BACTIDROP CALCOFLUOR WHITE (K960095)Remel Co.1996-03-19
SLOAN STA-DRI PANT PROTECTOR (K945302)Sloan Corp.1996-03-19
NON PRESCRIPTION SUN GLASSES (K960650)Solovision Optical, Inc.1996-03-19
VIVASPIN 4 10,000 MW (K960298)Vivascience, Inc.1996-03-19
CALCOFLUOR WHITE STAIN KIT (K960090)Remel Co.1996-03-19
NIOMED SURGICAL CAPS (K955833)Amerasia Corp.1996-03-15
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