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

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RecordFirmDate
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS (K990984)Ortho-Clinical Diagnostics, Inc.1999-04-08
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) (K990302)Instrumentation Laboratory CO1999-04-08
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 (K990888)Bio-Rad1999-04-07
PREPOWDERED NITRILE EXAMINATION GLOVES (K990499)Flexitech Sdn. Bhd.1999-04-02
POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM (K990501)Flexitech Sdn. Bhd.1999-04-02
POWDER FREE NITRILE EXAMINATION GLOVES (K990495)Flexitech Sdn. Bhd.1999-04-02
PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K990502)Flexitech Sdn. Bhd.1999-04-02
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE (K982505)Tillotson Healthcare Corp.1999-04-02
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW (K990664)Intracel Corp.1999-03-31
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 (K990424)Bio-Rad1999-03-31
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 (K990608)Bio-Rad1999-03-30
SAPHLIFT (K990062)Genzyme Surgical Product (Genzyme Biosurgery)1999-03-30
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) (K990420)La Glove (M) Sdn. Bhd.1999-03-29
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES (K990299)Shanghai Palomar Mountain Industries, Inc.1999-03-29
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS) (K984039)Cranberry (M) Sdn. Bhd.1999-03-29
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES (K990267)Shanghai Palomar Mountain Industries, Inc.1999-03-29
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) (K990415)La Glove (M) Sdn. Bhd.1999-03-29
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP (K990210)Mexpo Intl., Inc.1999-03-29
FLEXISCOPE OPTOMODUL (K984641)Schoelly Fiberoptic GmbH1999-03-29
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS (K990783)Ortho-Clinical Diagnostics, Inc.1999-03-25
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) (K990682)Nsk Nakanishi, Inc.1999-03-24
SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES (K990751)Southland Products Co., Ltd.1999-03-23
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (K990746)Southland Products Co., Ltd.1999-03-23
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES (K990013)Yty Industry (Manjung) Sdn Bhd1999-03-23
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 (K990393)Bio-Rad1999-03-22
TISPORT X AND TISPORT XC (K990555)Tisport1999-03-22
THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR (K990557)Pdg Product Design Group, Inc.1999-03-22
AIR TECHNIQUES' DENTO-VAC (K984584)Air Techniques, Inc.1999-03-22
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 (K990249)Phamatech1999-03-22
SAS HCG SERUM CONTROLS (K990720)Sa Scientific, Inc.1999-03-19
AROMAPATCH (K984345)Envis, Inc.1999-03-19
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM (K984449)P.T. Irama Dinamika Latex1999-03-19
SAS HCG URINE CONTROLS (K990755)Sa Scientific, Inc.1999-03-19
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE (K990646)Nsk Nakanishi, Inc.1999-03-19
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336)Diagnostic Products Corp.1999-03-18
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 (K990317)Bio-Rad1999-03-18
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 (K990394)Bio-Rad1999-03-18
RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 (K984521)Richard Wolf Medical Instruments Corp.1999-03-17
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 (K984466)Dilon Technologies, Inc.1999-03-16
BACK-ON-TRAC, MODEL 101BOT (K984190)Back-On-Track, Inc.1999-03-15
MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 (K983882)Micro-Medical Devices, Inc.1999-03-15
MEDLINE EXCEL WHEELCHAIRS (K990463)Medline1999-03-15
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 (K990391)Bio-Rad1999-03-15
ENTERO-TEST HP, MODEL #102-01 (K983119)Hdc Corp.1999-03-15
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) (K982600)Wembley Rubber Products (M) Sdn Bhd1999-03-12
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (K984518)Sonic Innovations, Inc.1999-03-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS (K990531)Ortho-Clinical Diagnostics, Inc.1999-03-12
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 (K990282)Bio-Rad1999-03-09
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR (K990453)Alliance Rubber Products Sdn. Bhd.1999-03-09
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K990283)Hartalega Sdn Bhd1999-03-09
EXMOOR SUCTION CLEARANCE KIT (K990366)Exmoor Plastics , Ltd.1999-03-05
RESTORE (AKA RE/STOR) (K983164)Nebl, Inc.1999-03-05
EBV-VCA IGG ELISA TEST SYSTEM (K981812)Diamedix Corp.1999-03-04
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K983071)Respironics, Inc.1999-03-04
VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES (K984596)Zymetx, Inc.1999-03-04
STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) (K981947)Boston Medical Corp.1999-03-03
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING (K984539)Ferris Mfg. Corp.1999-03-01
MTM BIOSCANNER K TEST STRIPS (K981865)Polymer Technology Systems, Inc.1999-02-26
CROSS SPORT, RIGID WHEELCHAIR (K990358)Tisport1999-02-26
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984558)Ansell Perry1999-02-26
ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984559)Ansell Perry1999-02-26
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV (K990377)Roche Diagnostics Corp.1999-02-26
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223)Unipath , Ltd.1999-02-24
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) (K990268)La Glove (M) Sdn. Bhd.1999-02-24
ORL-E-92 SURGICAL DRILL SYSTEM (K984244)Bien Air USA, Inc.1999-02-23
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K990117)Shanghai Palomar Mountain Industries, Inc.1999-02-19
NITRILE POWDER FREE EXAMINATION GLOVES (K983334)Cranberry (M) Sdn. Bhd.1999-02-19
GUTHRIE PRIME POWDER-FREE (K990228)Guthrie Medicare Products (Melaka) Sdn Bhd1999-02-19
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED (K990081)Shanghai Palomar Mountain Industries, Inc.1999-02-19
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S (K984544)Enteric Products, Inc.1999-02-18
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) (K990285)La Glove (M) Sdn. Bhd.1999-02-18
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) (K990270)La Glove (M) Sdn. Bhd.1999-02-18
CARE BAND ANTIBACTERIAL BANDAGES (K983368)Aso Corp.1999-02-17
POWDERED NITRILE EXAMINATION GLOVES (K984615)Shiva Medicare , Ltd.1999-02-17
MAGNETIC TIBC KIT (K990216)Reference Diagnostics, Inc.1999-02-16
IS EBV-EA-D IGG ELISA TEST SYSTEM (K981831)Diamedix Corp.1999-02-16
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (K981829)Diamedix Corp.1999-02-16
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED (K984309)Sumirubber Industries (Kedah) Sdn. Bhd.1999-02-12
SCAREASE & SCAREASE ADHESIVE GEL (K984115)Scarease, Inc.1999-02-12
UNI-GOLD STREP A TEST KIT (K982373)Trinity Biotech, Plc1999-02-11
NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE (K984311)Sumirubber Industries (Kedah) Sdn. Bhd.1999-02-09
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K984125)Kilang Barangan Getah Dioh1999-02-09
ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III (K984609)Lite Specialty Metal Works, Inc.1999-02-09
PRE-POWDER VINYL PATIENT EXAMINATION GLOVES (K984461)Shanghai Huamao Gloves Co., Ltd.1999-02-09
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K984460)Shanghai Huamao Gloves Co., Ltd.1999-02-09
RE NU (K973289)Pacific Rim Dental, Inc.1999-02-09
SCICAN CLASSIC (K984556)Scholly Fiberoptic GmbH1999-02-09
POWDER FREE NITRILE EXAMINATION GLOVES (K984610)Shiva Medicare , Ltd.1999-02-09
TCM 3000 AND TCM ENDO (K981679)NOUVAG AG1999-02-09
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (K984405)Intracom Corp.1999-02-08
GENICON TROCAR (K982472)Genicon, LC1999-02-04
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED) (K983614)American Healthcare Products (M) Sdn Bhd1999-02-04
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR (K990157)Invacare Corp.1999-02-03
MEROGEL NASAL DRESSING AND SINUS STENT (K982731)Xomed, Inc.1999-02-02
ELECSYS IGE CALCHECK (K984419)Boehringer Mannheim Corp.1999-02-02
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 (K984625)Bio-Rad1999-02-02
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 (K984604)Bio-Rad1999-02-02
OSTEOMARK NTX SERUM EIA (K983457)Ostex Intl., Inc.1999-02-02
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 (K984594)Bio-Rad1999-02-02
QUANTEX ASO-CRP-RP CONTROL II (K984437)Instrumentation Laboratory CO1999-02-02
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