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

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RecordFirmDate
BONE SAW BLADES (K931176)Betzler Mfg., Inc.1994-01-26
BARRIER BONE WAX APPLICATOR (K934260)Phillips Pharmaceuticals, Inc.1994-01-26
VISION PROPHY PASTE WITH FLUORIDE (K935925)Block Drug Company, Inc.1994-01-26
HYDRO-TRED/AIR POWERED TREADMILL (K931723)Santa FE Swim Systems1994-01-26
DENTAL INSTRUMENTS SCALER (K931330)Minnesota Prophy Power, Inc.1994-01-26
FORESTADENT ORTHODONTIC BANDS (K925028)Forestadent1994-01-26
DISPOSE-A-SHEET (K933636)Belmac Healthcare Corp.1994-01-26
FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE (K926262)Sgarlato Laboratories, Inc.1994-01-26
MOTORIZED ELECTRIC PARALLEL BARS (K933311)Midland Mfg. Co.1994-01-26
LARIAT PALATE EXPANDER (K926427)Easy Access Orthodontics, Inc.1994-01-26
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT (K935561)Bausch & Lomb, Inc.1994-01-26
DENTAL LIGHT (K926081)Mdt Corp., Inc.1994-01-26
MEDIMAC BANDAGE (K930457)Enquay Pharmaceutical1994-01-25
SPECTACLE FRAMES AND SUNGLASSES (K933189)Eastern Breeze Intl. Co.1994-01-25
COMPOUND BENZOIN TINCTURE USP SEPP (K923516)Medi-Flex Hospital Products, Inc.1994-01-25
COMPOUND BENZOIN TINCTURE USP FREPP (K920399)Medi-Flex Hospital Products, Inc.1994-01-25
GLASSES MOLASSES (K930174)Arthur F. Kozakowski, Jr.1994-01-25
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (K933527)Mira, Inc.1994-01-25
MODIFIED SITE POWER HANDPIECE II (K932600)Chiron Vision Corp.1994-01-25
ARTHREX AR-8200 SHAVER SYSTEM (K932699)Arthrex, Inc.1994-01-25
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS (K935070)KARL STORZ Endoscopy-America, Inc.1994-01-25
SPECTACLE FRAMES AND SUNGLASSES (K934187)Wah Ming Optical Mfy. , Ltd.1994-01-25
ELECTRIC I/V POLE OR EIVP2 (K935003)Optical Micro Systems, Inc.1994-01-25
TALE SPIN SUNSHADES (K935231)Equity Marketing, Inc.1994-01-25
OLYMPUS IMAGEMANAGERSYSTEM (K934888)Olympus1994-01-25
TEC 2100 (MODEL MT-LPLGD) (K935760)Medtec, Inc.1994-01-25
APEX OPTICAL IND. CO., EYE WEA MODELS (K932821)Apex Optical Ind. Co.1994-01-25
OPTIKOS SHAMI, INC. SUNGLASSES (K934197)Optikos Shami, Inc.1994-01-25
SPECTACLE FRAMES (K935107)Mr I'S Optical Boutique1994-01-25
SPECTACLE FRAME/EYEGLASS FRAME (K935558)Modern Optical , Ltd.1994-01-25
ENDOSTAR(TM) STYLET (K933598)Fiberoptic Medical Products, Inc.1994-01-25
SURGITEL (K934494)General Scientific Corp.1994-01-25
SUNGLASSES (K933223)Rally Accessories, Inc.1994-01-25
COOL KIDS MIRROR SHADES (K934402)Ja-Ru, Inc.1994-01-25
HEPA FILTERED HEAT AND MOISTURE EXCHANGER (K935036)Intertech Resources, Inc.1994-01-25
MALE/MALE LUER TRANSFER TUBING (K932780)Innovations For Mechanical Ventilation, Inc.1994-01-24
DUAL VALVED RESPIRATORY T (K932781)Innovations For Mechanical Ventilation, Inc.1994-01-24
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS (K935766)Advanced Clinical Diagnostics1994-01-24
NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID (K935329)Nu-Ear Electronics1994-01-21
CHANNEL-EDGE BRACKET SYSTEM (K930881)Dualtek, Inc.1994-01-21
ISOLAIR 2 FULL FACE SPLASH GUARD (K931288)Louis M. Gerson Co., Inc.1994-01-21
NU.EAR SD-1 IN THE EAR (ITE) HEARING AID (K935334)Nu-Ear Electronics1994-01-21
FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (K934265)Flexmedics1994-01-21
NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID (K935330)Nu-Ear Electronics1994-01-21
SODEM POWER SYSTEM (K935567)Sodemsystems1994-01-21
NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID (K935327)Nu-Ear Electronics1994-01-21
ACCU-PATH (K935250)Cox Medical Ent., Inc.1994-01-21
COMFORT PLUS NIPPLE SHIELDS (K935340)Marshall Baby Products1994-01-21
CP & S STERILE BURN SHEET (K930759)Consolidated Products & Services, Inc.1994-01-21
COMFORT PLUS BREAST SHELLS (K935341)Marshall Baby Products1994-01-21
BIO-PREP (K931846)Biomedical Devices, Inc.1994-01-21
QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE (K931093)Dentalez Group1994-01-21
NU-EAR SD-10 IN THE CANAL HEARING AID (K935326)Nu-Ear Electronics1994-01-21
NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID (K935335)Nu-Ear Electronics1994-01-21
NU.EAR SS-1 IN THE EAR (ITE) HEARING AID (K935333)Nu-Ear Electronics1994-01-21
NU.EAR AE-1 IN THE EAR (ITE) HEARING AID (K935332)Nu-Ear Electronics1994-01-21
NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID (K935331)Nu-Ear Electronics1994-01-21
NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID (K935328)Nu-Ear Electronics1994-01-21
REGENCY PLUS BRACKET (K933758)Mid-American Dental Specialties, Inc.1994-01-18
ALRAND INC. (DENTAL HAND INSTRUMENTS) (K926190)Alrand, Inc.1994-01-18
APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK (K923299)Aplicare, Inc.1994-01-18
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP (K935553)Puritas Health Care, Inc.1994-01-14
TUBE, INHALER OXYGEN (K935582)Puritas Health Care, Inc.1994-01-14
DOUBLE TRACH SWIVEL CONNECTOR (K935821)Nutec, Inc.1994-01-14
ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS (K930796)Alko Diagnostic Corp.1994-01-13
POWDER FREE LATEX EXAMINATION GLOVES (K931521)Pt. Abbergummi Medical1994-01-13
ALANINE AMINOTRANSFERASE (ALT) TEST (K935180)Em Diagnostic Systems, Inc.1994-01-13
BINAURAL HEARING AID (K935366)Telex Communications, Inc.1994-01-13
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (K935835)Busse Hospital Disposables, Inc.1994-01-12
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (K935797)Stebar Instrument Corp.1994-01-12
ALLKARE BARRIER WIPE (K925004)Convatec, A Division of E.R. Squibb & Sons1994-01-12
ENTREE CANNULA FASCIA ANCHORS (K932021)Core Dynamics, Inc.1994-01-11
SPQ PAL CONTROL LEVEL II (K934966)Incstar Corp.1994-01-11
BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT (K933078)Beckman Instruments, Inc.1994-01-11
IMMULITE PROGESTERONE (K935138)Diagnostic Products Corp.1994-01-11
MODEL 5500 CEAS (K934977)Esa, Inc.1994-01-11
ONE STEP LH TEST (K935134)Tcpi, Inc.1994-01-11
N-ASSAY TIA MICROALBUMIN (K934146)Crestat Diagnostics, Inc.1994-01-11
ACE BASIC DENTAL IMPLANT PACK I (K922652)Ace Surgical Supply Co., Inc.1994-01-10
ACE DENTAL IMPLANT KIT (K922651)Ace Surgical Supply Co., Inc.1994-01-10
CHOLESTEROL ENZYMATIC ENDPOINT (K923504)Randox Laboratories, Ltd.1994-01-10
IMMULITE ESTRADIOL (K932926)Diagnostic Products Corp.1994-01-10
BRENNEN MEDICAL STERILE SALINE SOLUTION (K935060)Brennen Medical, Inc.1994-01-10
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (K934727)Cardiac Pacemakers, Inc.1994-01-10
ACE BASIC DENTAL IMPLANT PACK II (K922649)Ace Surgical Supply Co., Inc.1994-01-10
ACTIVE ANDROSTANEDIOL GLUCURONIDE (K934751)Diagnostic Systems Laboratories, Inc.1994-01-10
ACE DENTAL IMPLANT CUSTOM SURGICAL PACK (K922650)Ace Surgical Supply Co., Inc.1994-01-10
COMPACT MASK (K932347)Vital Signs, Inc.1994-01-10
OSTEON ADAPTOR/CRADLE (K930319)United American Medical Co., Inc.1994-01-07
ACUFEX STERILE DRILLS (K931837)Acufex Microsurgical, Inc.1994-01-07
HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (K931737)Synvasive Technology, Inc.1994-01-07
ALPINE REUSABLE LEG BAGS (K934052)Sierra Laboratories, Inc.1994-01-07
SILICONE GEL SHEETING (K932048)Silipos, Inc.1994-01-07
CAMERA, SURGICAL AND ACCESSORIES (K934092)Envision Medical Corp.1994-01-07
BIOPSY PUNCH, SURGICAL (K933670)Byron Medical1994-01-07
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (K932307)3M Health Care, Ltd.1994-01-07
SURGICAL CURETTE (K932493)Whitney Products, Inc.1994-01-07
PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) (K934133)Supergrade Healthcare Products Sdn. Bhd.1994-01-07
ES-100 ACCESSORIES (K932261)Elekta Instruments, Inc.1994-01-07
WIZARD PEDIATRIC WHEELCHAIR (K934560)Snug Seat, Inc.1994-01-07
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