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

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RecordFirmDate
NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (K913421)Specialty Packaging Producs, Inc.1991-10-18
PEDIA PALS (K911650)Pedia Pals, Inc.1991-10-17
DUCAL SIDE SHIELD SUNGLASS (K913745)Ducal Trading Corp.1991-10-15
COLLAGEN SHIELD FOR ACUTE CARE (K913148)Vitaphore Corp.1991-10-15
WIZARD STERILIZED ELECTROEPILATION NEEDLE (K911983)Skin Deep, Inc.1991-10-15
RADIOGRAPHIC FILM MARKING SYSTEM (K913478)Lorad Medical Systems, Inc.1991-10-15
OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (K912763)Medical Fittings, Inc.1991-10-15
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY (K905211)Vitek Systems, Inc.1991-10-11
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION (K914333)Siemens Hearing Instruments, Inc.1991-10-11
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE (K914202)Baxter Diagnostics, Inc.1991-10-11
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST (K912255)Hycor Biomedical, Inc.1991-10-11
VISI-NEISSERIA (K913456)Kev Connecticut Diagnostics, Inc.1991-10-11
GUARDIAN GEL, SURGEON'S GLOVING CREAM (K910687)Guardian Angel Products, Inc.1991-10-11
FLEX-ELBOW (K912652)Vital Signs, Inc.1991-10-10
VENTURI OXYGEN MASK (K913275)Specialty Packaging Producs, Inc.1991-10-10
BERMAN INTUBATING/PHARYNGEAL AIRWAY (K913680)Chain Plastics Operations, Inc.1991-10-10
AEROBIC FOAM SWAB CULTURETTE(R) (K913789)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-09
ICAN CYLINDRICAL SPONGES (K914086)Icn Pharmaceuticals, Inc.1991-10-09
A-DEC DECADE 1020 CHAIR (K913535)A-Dec, Inc.1991-10-09
ICAN COTTON RAYON BALLS (K914081)Icn Pharmaceuticals, Inc.1991-10-09
PULPDENT POLYAMIDE DENTIN LINER (K911285)Pulpdent Corp.1991-10-09
ICAN K DISSECTOR SPONGES (K914083)Icn Pharmaceuticals, Inc.1991-10-09
BUTTERFLY DRESSING (K912160)Durden Enterprises, Inc.1991-10-09
CCI VIDEOKERATOSCOPE/COMPARATOR (K913022)Cci1991-10-09
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (K913705)Em Diagnostic Systems, Inc.1991-10-09
A-DEC KNEEBREAK 1030 CHAIR (K913059)A-Dec, Inc.1991-10-08
STERILE CHEST TUBE (K913733)Vascular Products, Inc.1991-10-08
MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV (K912737)Medical Armor Corp.1991-10-08
ORTHODONTIC WIRE (K911231)Masel Industries, Inc.1991-10-08
AUGUSTINE GUIDE KIT WITH GAUZE SPONGE (K914168)Augustine Medical, Inc.1991-10-07
AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST (K911362)Amico Laboratories, Inc.1991-10-07
VIBRATOUCH II CORDLESS WAND MASSAGER (K912383)Conair Corp.1991-10-07
COX DISPOSABLE BIOPSY FORCEP (K913883)Cox Medical Ent., Inc.1991-10-05
DISPOSABLE BOUFFANT CAP (K913700)Gem Nonwovews, Inc.1991-10-04
URI-THREE(TM), MODIFICATION (K911846)Culture Kits, Inc.1991-10-04
WELLPREP 1 (K913567)Denley Instruments, Inc.1991-10-04
MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO (K912457)Medical Armor Corp.1991-10-04
PYLORITRAK (K912215)Bainbridge Laboratories, Inc.1991-10-04
DISPOSABLE SHOE COVER (K913628)Gem Nonwovews, Inc.1991-10-04
BANDAGE COMPRESS (K912952)Cal West Trading Co.1991-10-04
CONFORMING BANDAGE (K912692)Ulti-Med Intl., Inc.1991-10-04
SILICONE MALE EXTERNAL CATHETER (K913524)Mentor Corp.1991-10-04
POST OPERATIVE SPONGE (K912693)Ulti-Med Intl., Inc.1991-10-04
COMPRESS DRESSING (K912950)Cal West Trading Co.1991-10-04
UNIDIRECTIONAL OCCLUDER (K913230)Welch Allyn, Inc.1991-10-02
OXYGEN MASKS 82400 & 82405 (K913455)Specialty Packaging Producs, Inc.1991-10-02
PDI PARALLEL SIDED POST KIT (K913019)Precident Corp.1991-10-02
EYE BUBBLE (K912367)Aaron Medical Industries1991-10-02
DEROYAL WOUND DRESSING (K912472)Deroyal Industries, Inc.1991-10-02
THE PAN.OPTX SPORTGLASS (K913388)Panoptx, Inc.1991-10-02
INSTANT WARM GEL PACK (K912715)Prism Technologies, Inc.1991-10-02
PERRY(R) DERMAGUARD(R) PLUS GLOVES (K913402)Smith & Nephew Perry1991-10-02
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 (K914069)Medical Analysis Systems, Inc.1991-10-02
HANN-VAC TM, DISPOSABLE,SUCTION CATHETER (K903480)Un-I-Med, Inc.1991-10-01
LARYNGOSCOPE (K912905)Acorn Group, Inc.1991-09-30
SILICONE GEL SHEETING (K913140)Cui Corp.1991-09-30
GAUZE COMPRESS (K912953)Cal West Trading Co.1991-09-30
PROLACTIN IRMA IMMUNOMAG (K914107)Pantex, Div. Bio-Analysis, Inc.1991-09-30
WHITER BITER CROWN (K913152)George M. Wilson, Dds1991-09-30
MICROTAK PLUS (K913840)Syva Co.1991-09-30
DENTAL FLOSS (K913087)Westone Products , Ltd.1991-09-30
GAUZE SPONGE,STERILE 2'S (K912779)Keilei Intl., Inc.1991-09-30
MAX-I-PROBE IRRIGATION SYSTEM (K913030)Smith & Nephew, Inc.1991-09-30
DENTAL FLOSS (K912430)Westone Products , Ltd.1991-09-30
OPERAND LUBRICATING JELLY (K912975)General Medical Co.1991-09-27
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) (K913133)Bionostics, Inc.1991-09-27
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (K914033)Cholestech Corp.1991-09-27
LATEX EXAMINATION GLOVES (K913409)Top Glove Sdn. Bhd.1991-09-27
ENZYMUN-TEST ESTRADIOL (K913162)Boehringer Mannheim Corp.1991-09-27
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST (K912499)King Diagnostics, Inc.1991-09-27
RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR (K913621)Rinn Dental Products1991-09-27
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (K912838)Baxter Diagnostics, Inc.1991-09-27
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 (K913706)Em Diagnostic Systems, Inc.1991-09-27
STRATUS IINTELLECT IMMUNOASSAY SYSTEM (K913130)Baxter Healthcare Corp1991-09-27
J&S IRON REAGENTS (K912716)J.S. Medical Assoc.1991-09-25
LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE (K912839)Baxter Healthcare Corp1991-09-25
LIPID LINEARITY CONTROLS (K913224)Creative Laboratory Products, Inc.1991-09-25
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III (K913677)Analytical Control Systems, Inc.1991-09-25
DESERT SHIELD SUNGLASSES (K912863)Command Marketing Corp.1991-09-25
KODAK EKTACHEM DT SLIDES (LIPASE) (K913196)Eastman Kodak Company1991-09-25
QUANTIMETRIX AMMONIA CONTROLS (K913346)Quantimetrix Corp.1991-09-25
SELF-CONTAINED SURGICAL SLUSH FREEZER (K913777)Taylor Corp.1991-09-25
J&S UIBC REAGENTS (K912717)J.S. Medical Assoc.1991-09-25
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 (K913079)Lucas Sensing Systems, Inc.1991-09-25
IV HOUSE (K912942)Progressive Iv'S, Inc.1991-09-25
EBNA STAT TEST KIT (K911473)Whittaker Bioproducts, Inc.1991-09-25
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL (K913792)Hichem Diagnostics1991-09-25
B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES (K913902)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-09-25
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (K912843)Flexmedics1991-09-24
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY (K913234)Varian Canada, Inc.1991-09-23
NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (K911784)North American Sterilization & Packaging Co.1991-09-23
BACTIDROP(TM) VOGES-PROSKAUER B (K913007)Remel Co.1991-09-23
BACTIDROP(TM) FERRIC CHLORIDE (10%) (K913002)Remel Co.1991-09-23
PROBE LATEX EXAMINATION GLOVES - STERILE (K912392)Glovetex Industries1991-09-23
LATEX EXAMINATION GLOVES (K913279)Liwe Trading1991-09-23
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B (K912749)Medical Analysis Systems, Inc.1991-09-23
BACTIDROP(TM) DOBELL & O'CONNOR IODINE (K913006)Remel Co.1991-09-23
BACTIDROP(TM) OXIDASE (K913008)Remel Co.1991-09-23
SURGIFIT STERILE SURGICAL GLOVES (K913215)Hevealactics Intl. Sdn Bhd1991-09-23
BACTIDROP(TM) VOGES-PROSKAUER A (K913003)Remel Co.1991-09-23
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