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

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RecordFirmDate
VINYL SILICONE ELASTOMER MATERIAL (K901990)Crown Delta Corp.1990-09-14
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 (K903650)Micro-Aire Surgical Instruments, Inc.1990-09-14
PDS-2000 (K902653)Intl. Equipment and Supply Corp.1990-09-13
TEFLON CERVICAL ACCESS SET (K896701)Cook Ob/Gyn1990-09-13
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM (K901840)Granbio, Inc.1990-09-12
ANOLIFT - PORTABLE & ANOLIFT - GANTRY (K902141)Anodyne Corp.1990-09-12
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (K901156)Granbio, Inc.1990-09-12
ALANINE AMINOTRANSFERASE TEST (K903198)Em Diagnostic Systems, Inc.1990-09-12
ALERT BED ALARM SYSTEM (K901969)Alertronics, Inc.1990-09-12
GENESIS INSUFFLATING CATHETER (K903669)General Medical Co.1990-09-12
DYNASTY HEARING SYSTEMS INSTRUMENT (K900632)Alastair Granville-Jackson, Mfa, Ed.D.1990-09-12
PATIENT EXAMINATION GLOVES (K903289)Pacificlink Export Industries Private , Ltd.1990-09-12
LATEX FINGER COTS (K903073)Dongkuk Trading Co., Ltd.1990-09-12
FIBER OPTIC LIGHT SOURCE (K902784)Trek Medical Products, Inc.1990-09-12
OLYMPUS INORGANIC PHOSPHORUS (K903696)Em Diagnostic Systems, Inc.1990-09-12
SYVA MICROTRAK EIA ACCESSORY REAGENTS (K903758)Syva Co.1990-09-12
TRAUMA SLEEVE (K901509)Haz-Med, Inc.1990-09-12
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (K903647)Millipore Corp.1990-09-11
TIPSTOP(TM) (K896068)Gambro-Hospal, Inc.1990-09-10
DIRECTIGEN FLU A (K902609)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-09-10
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) (K903616)Diagnostic Systems Laboratories, Inc.1990-09-10
BAUMER SURGICAL TABLE (K902865)Sds Dental, Inc.1990-09-10
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH (K903510)Helm Toy Corp.1990-09-10
MODIFICATION TO API UNISCEPT 20GP (K901559)Analytical Products, Inc.1990-09-10
FRAME, SPECTACLE (K903949)Eureka Optics, Inc.1990-09-10
MODIFIED LYOFOAM WOUND DRESSINGS (K895764)Acme United Corp.1990-09-10
RAD-X GLASSES (K902280)Compudrug1990-09-10
AIA-PACK IRI (K903628)Tosoh Corp.1990-09-07
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR (K903310)Medical Analysis Systems, Inc.1990-09-07
KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL (K903338)Kenlor Industries, Inc.1990-09-07
SURGICAL COTTON GLOVES (K900425)Allo Pro Corp.1990-09-07
AFFINITY HLH TEST SYSTEM (K903407)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-09-07
ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL (K903767)Siemens Gammasonics, Inc.1990-09-07
DISPENSA-LUBE (K903717)Gam-Med Packaging Corp.1990-09-06
DENTURE DYNAMIC'S DENTURE MAGIC (K902838)Denture Dynamic'S, Inc.1990-09-06
PROPHY PASTE (K901580)Dentsply Intl.1990-09-06
SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER (K902349)Surgitek1990-09-05
N-DEX (K902696)Moss Point Glove Co.1990-09-05
OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS (K903214)Medical Fittings, Inc.1990-09-05
SAFETY FIRST (K902708)Bright Rubber Industries Private , Ltd.1990-09-05
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (K902220)Boehringer Mannheim Corp.1990-09-05
COMFIT, PATIENT EXAMINATION GLOVES (K903746)Wembley Rubber Products (M) Sdn Bhd1990-09-05
PM GLOVES (MFG: BJL GLOVE (M) SDN.BHD.) (K902670)Pm Gloves, Inc.1990-09-05
ESCORT ITC (K903295)Hearing Tech, Inc.1990-09-05
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET (K903969)Karlin Technology, Inc.1990-09-05
STERILE PATIENT EXAMINATION GLOVES (K903756)Tillotson Rubber Co., Inc.1990-09-05
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA (K901972)Novo Nordisk Diagnostics, Ltd.1990-09-05
FLOSSIE TOOTHFLOSS (K903712)Flossie, Inc.1990-09-05
NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN (K902844)Progressive Dental Supply1990-09-05
MANAN BONE BIOPSY NEEDLE (K902177)Manan Medical Products, Inc.1990-09-05
ZEROWET SPLASHIELD (K900208)Zerowet Splashield1990-09-04
VENTLAB VENT-MASK, CAT# VR 0010/20/30 (K903881)Ventlab Corp.1990-09-04
SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (K900472)Skytron, Div. the Kmw Group, Inc.1990-09-04
GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS (K902632)Marquest Medical Products, Inc.1990-09-04
MEDI, CURI EXAM GLOVES (K893060)Golden Charter , Ltd.1990-09-04
CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS (K903544)J.J. Skinner, Inc.1990-08-31
THE MONITOR ELECTRONIC BED ALARM SYSTEM (K901330)The Monitor Corp.1990-08-30
PERLINK SCREEN, KIRAN SCREEN (K896707)Perlink USA, Inc.1990-08-30
GRAVITY ASSIST (K902854)Instrument Makar, Inc.1990-08-29
STAT TEST HDL/CHOLESTEROL TEST KIT (K903094)Diagnostic Resources, Inc.1990-08-29
PATIENT EXAMINATION GLOVE (K902770)Mastri Lieno, PT1990-08-29
IMMUNOCORP LH IRMA COATED TUBE (K903052)Immunocorp Sciences, Inc.1990-08-29
TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (K903306)Technicon Instruments Corp.1990-08-29
PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER) (K903108)Ansell, Inc.1990-08-29
ELANTEC'S SURGICAL TAPE REMOVER (K902009)Elantec, Inc.1990-08-29
STERI-CATH-DL (K902687)Concord/Portex1990-08-29
PVC PATIENT EXAMINATION GLOVE (K902278)Fujian Province Jiu Zhou Group1990-08-29
PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER) (K903107)Ansell, Inc.1990-08-29
ARGILITE 4 GOLD ALLOY FOR PORCELAIN (K903686)Argen Precious Metals, Inc.1990-08-29
MPS DIAMOND POLISHING GEL (K903003)Abrasive Technology, Inc.1990-08-29
CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) (K902460)Oakfield Instruments, Ltd.1990-08-28
SUNGLASSES (K897090)Pt Midas Surya Optical Co.1990-08-28
TOY SUNGLASSES (K903202)Creative Design1990-08-28
YSI MODEL 1500 SPORT L-LACTATE ANALYZER (K901131)Yellow Springs Instrument Co., Inc.1990-08-27
DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) (K902441)Currie Medical Specialties, Inc.1990-08-23
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR) (K901225)Abbott Laboratories1990-08-23
PROLAX DISPOSABLE LATEX GLOVES (EXAM) HYPOALLERGEN (K903350)Prolax Medical Products, Inc.1990-08-23
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE (K897077)Gen-Probe, Inc.1990-08-23
PROLAX DISPOSABLE LATEX GLOVES (EXAMINATION) (K903352)Prolax Medical Products, Inc.1990-08-23
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST (K896494)Gen-Probe, Inc.1990-08-23
LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 (K903430)Bio-Rad1990-08-23
STANBIO CSF/URINE TOTAL PROTEIN TEST SET (K902204)Stanbio Laboratory1990-08-22
REDITEST STREP A TEST KIT (K903194)Boehringer Mannheim Corp.1990-08-22
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (K903359)Immunotech Corp.1990-08-22
LYMPHO SEP(TM) (K902445)Icn Biomedicals, Inc.1990-08-22
ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS (K902298)Rondex Products, Inc.1990-08-22
MAGNESIUM (K903341)Catachem, Inc.1990-08-22
KODATROL LIQUID CONTROL LEVELS I & II (K903189)Eastman Kodak Company1990-08-22
FLORA-STAT URINE TRANSPORT SYSTEM (K902467)Wadley Biosciences Corp.1990-08-22
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL (K902909)Creative Laboratory Products, Inc.1990-08-22
WHENEVER(R) UNSCENTED SUPER MAXI PAD (K901690)Marcal Paper Mills, Inc.1990-08-21
SABA CONFORT MENSTRUAL PAD (K902160)Valle & Assoc.1990-08-21
O. B. PACK III (K902273)Customed, Inc.1990-08-21
KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD (K902000)Kevtek Medical Products, Inc.1990-08-21
PATIENT EXAMINATION GLOVES (K903656)United Rubber Corp. (Sabah) Sdn. Bhd.1990-08-21
ANESTHESIA BREATHING CIRCUITS (K900428)Med-Tek Corp.1990-08-17
POWDER FREE, NON-STERILE EXAMINATION GLOVES (K903607)Tillotson Rubber Co., Inc.1990-08-17
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY (K903190)Medical Analysis Systems, Inc.1990-08-17
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT (K903225)Medical Analysis Systems, Inc.1990-08-17
COLLAGEN SHIELD FOR ACUTE CARE (K902558)Vitaphore Corp.1990-08-17
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