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

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RecordFirmDate
REVERSE SURVE NITI ARCH WIRE (K933380)Highland Metals1993-11-12
BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO (K926477)Core Dynamics, Inc.1993-11-12
MODIFICATION OF SURGICAL EYESHIELD MASK (K934085)American Threshold Industries, Inc.1993-11-12
REVO CLASSIC/SHAPES SUNGLASSES (K934400)Revo, Inc.1993-11-12
NUCLEAR ASSOCIATES GLASSERS (K934362)Victoreen, Inc.1993-11-12
STAINLESS STEEL ARCHES (K933379)Highland Metals1993-11-12
NITI ARCH WIRE ON A SPOOL (K933376)Highland Metals1993-11-12
SUNGLASSES (K930585)Daiko S.R.L.1993-11-12
AUTOBEAD THYROID UPTAKE (K930689)Bio-Chem Laboratory Systems, Inc.1993-11-10
AIA-PACK E2 ASSAY (K932084)Tosoh Medics, Inc.1993-11-09
IRON/UIBC REAGENT (K932517)Sigma Diagnostics, Inc.1993-11-09
MITEK CONE WASHER (K930675)Mitek Surgical Products, Inc.1993-11-09
DUPONT ACA URINE METHADONE CONTROL (K934145)E.I. Dupont DE Nemours & Co., Inc.1993-11-09
BECKMAN SYNCHRON LACTATE REAGENT (K934271)Beckman-Diagnostic Systems Group1993-11-09
DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH (K925653)Dermatopathology Laboratory1993-11-08
PC-MINI (K934367)GE Medical Systems1993-11-08
SILICONE MIRROR (K932511)Moyco Industries, Inc.1993-11-05
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS (K931443)Ortho Diagnostic Systems, Inc.1993-11-05
CARAPACE INCISION AND DRAINAGE TRAYS (K931597)Carapace, Inc.1993-11-05
SYNELISA PROGESTERONE (K933128)Elias U.S.A., Inc.1993-11-05
BIOPSY FORCEPS (K925392)Endo-Therapeutics, Inc.1993-11-05
VISI-SPOT (K932752)J.S. Medical Assoc.1993-11-05
POWERMATIC MAT PLATFORM (K933578)Medical Device Inspection Co., Inc.1993-11-05
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM (K932467)Instrumentation Laboratory CO1993-11-05
POWER WORK TABLE (K933580)Medical Device Inspection Co., Inc.1993-11-05
POWERMATIC TREATMENT TABLE (K933581)Medical Device Inspection Co., Inc.1993-11-05
TALC DISPENSER SYRINGE (K930610)Nusurg, Inc.1993-11-04
LIGHTSPEED DENTAL HAND INSTRUMENT (K932529)Lightspeed Endodontics1993-11-04
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM (K931372)Resound Corp.1993-11-03
IMPAX 1000 (K933409)Heraeus Kulzer, Inc.1993-11-03
PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL (K934585)Lafayette Pharmaceuticals, Inc.1993-11-03
DOCTOR DOWN --RESCUE WRAP (K932539)Three Dog Down1993-11-02
SUNGLASSES (K931990)American Eye Way, Inc.1993-11-02
V-SIL (K933546)Esschem, Inc.1993-11-02
CHILD NONPRESCRIPTION SUNGLASSES (K934308)U.S. Toy Co., Inc.1993-11-02
VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 (K933181)Valleylab, Inc.1993-11-02
TRACTION PRODUCTIONS SPECTACLE FRAMES (K934249)Traction Productions, USA1993-11-02
GLASSES (K931451)Siegel Optik1993-11-02
DISCO SUNGLASSES NONPRESCRIPTION SUNGLASSES (K934309)U.S. Toy Co., Inc.1993-11-02
EH-270 CORNEAL TOPOGRAPHER (K933556)Visioptic, Inc.1993-11-02
BUTTERFLY NONPRESCRIPTION SUNGLASSES (K934307)U.S. Toy Co., Inc.1993-11-02
ANIMAL NONPRESCRIPTION SUNGLASSES (K934304)U.S. Toy Co., Inc.1993-11-02
AVIATOR NONPRESCRIPTION SUNGLASSES (K934305)U.S. Toy Co., Inc.1993-11-02
PROMOTIONAL SUNGALSSES (K932416)Associated Premium Corp.1993-11-02
AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH (K933597)Arthro-Medic, Inc.1993-11-01
PORTABLE STANDARD (K934263)Cloverleaf Cycle Co.1993-11-01
DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR (K934297)Durable Medical Equipment, Inc.1993-11-01
ELS 1000 (K933548)Bio-Tek Instruments, Inc.1993-10-29
FAN BEAM COLLIMATOR (K933256)Siemens Gammasonics, Inc.1993-10-29
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 (K933437)Baxter Diagnostics, Inc.1993-10-28
BACTICARD STREP (K933514)Remel Co.1993-10-28
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER (K925991)Convatec, A Division of E.R. Squibb & Sons1993-10-28
DUODERM HYDROACTIVE DRESSING (K925993)Convatec, A Division of E.R. Squibb & Sons1993-10-28
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 (K932660)More Diagnostics1993-10-28
BECKMAN CHOLESTEROL REAGENT (K934046)Beckman-Diagnostic Systems Group1993-10-28
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL (K932442)Helena Laboratories1993-10-28
DUODERM EXTRA THIN CGF DRESSING (K925990)Convatec, A Division of E.R. Squibb & Sons1993-10-28
MOBILE CARE IV STAND (K932498)Mobile Care, Inc.1993-10-27
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM (K933319)Birtcher Medical Systems, Inc.1993-10-27
AVITENE DISPENSER SYRINGE (K924517)Nusurg, Inc.1993-10-27
STAR BREATHING CIRCUITS (K934753)Infrasonics Corp.1993-10-27
THE DE SOUTTER M182 DRILL (K930785)De Soutter Medical, Ltd.1993-10-27
BECKMAN CX AMMONIA/ALCOHOL CONTROL (K934467)Beckman-Diagnostic Systems Group1993-10-27
ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS (K934172)Acro-Poly, Inc.1993-10-27
THE DE SOUTTER M193 REAMER (K930784)De Soutter Medical, Ltd.1993-10-27
MODEL 9100 H.R. INFANT SCALE (K926174)Acme Medical Scale Co.1993-10-25
POWDER-FREE LATEX PATIENT EXAMINATION GLOVES (K931633)Tomarc (M) Sdn Bhd1993-10-25
1500 SERIES REGULATOR (K932006)Precision Medical, Inc.1993-10-25
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY (K933464)Baxter Diagnostics, Inc.1993-10-22
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (K933329)King Diagnostics, Inc.1993-10-22
AIA-PACK(R) PROG ASSAY (K933269)Tosoh Medics, Inc.1993-10-22
PROGESTERONE RADIOIMMUNOASSAY KIT (K931228)Immunotech Corp.1993-10-22
TSA 2001 THERMAL SENSORY ANALYZER (K922052)Medoc Corp.1993-10-21
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 (K934357)Bio-Rad1993-10-21
POWDER-FREE PATIENT EXAMINATION GLOVES (K931406)P.T. Healthcare Glovindo1993-10-21
AUKUSLEEVE (K930094)Aukland Medical Plastics, Inc.1993-10-20
A-DEC 2611 ASSISTANT'S CART (K933166)A-Dec, Inc.1993-10-20
PROFILE SERIES 29 FILES (K933582)Tulsa Dental Products, Ltd.1993-10-20
ORMCO SPORTSGUARD (K922806)Ormco Corp.1993-10-20
SIGMA-BRILLEN (OR) MULTIPLE (K930956)Sigma-Brillen1993-10-20
MODISSA 90 S.R.L. SUNGLASSES (K930858)Modissa 90 Srl1993-10-20
EYEGLASSES FRAMES (K933529)Vistula Assistance & Consulting Bureau1993-10-20
ALDO'S OPTICAL FRAME COLLECTION (K933956)Frontier Novelty, Inc.1993-10-18
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 (K934056)Medical Analysis Systems, Inc.1993-10-18
FRAMES (K933865)Hillman'S, the Eyecare Co., Inc.1993-10-18
FASHION ITALIANA EYEWEAR (K933089)Fashion Italiana, Inc.1993-10-18
OPTO LINE SRL (K933809)Optoline S.R.L.1993-10-18
LD 400 (K930937)Vismed, Inc.1993-10-18
SPECTACLE FRAMES (K933991)U.S. Optical1993-10-18
MUGNIER JERIK SUNGLASSES (K933718)Huntley Global Ent.1993-10-18
NON-PRESCRIPTION EYEGLASS FRAMES & SUNGLASSES VARIOUS STYLES (K934120)Lux DE Paris, Inc.1993-10-18
FRAME-SPECTACLE (K933765)Clearvision Optical Co., Inc.1993-10-18
SPECTACLE SUNGLASSES (NON-PERSCRIPTION) (K934034)H.M.O. Optical, Inc.1993-10-18
SPECTACLE FRAMES (K933891)Euro Frame Design, Inc.1993-10-18
ASICS SUNGLASSES (K933905)Asics Tiger Corp.1993-10-18
WINDMERE PRELUDE III (K924237)Windmere Corp.1993-10-18
SPECTACLE SUN GLASSES (NON PRESCRIPTION) (K934081)South American Optical, Inc.1993-10-18
SPECTACLE FRAMES (K934082)South American Optical, Inc.1993-10-18
DUODERM TRANSPARENT HYDROCOLLOID DRESSING (K925992)Convatec, A Division of E.R. Squibb & Sons1993-10-15
CUTO(TM) TISSUE MORCELLATION SYSTEM (K932700)Linvatec Corp.1993-10-15
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