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

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RecordFirmDate
POWDERFREE GREEN LATEX EXAMINATION GLOVES (K982285)Besglove Medicare Sdn. Bhd.1998-08-03
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES (K980106)Proma, Inc.1998-08-03
VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE (K982015)Taian Plastics Products (Jingxing) Co., Ltd.1998-08-03
DIRECT HDL (K981224)Abbott Laboratories1998-08-03
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) (K981181)Actimed Laboratories, Inc.1998-08-03
IMAGEQUEST (K974707)Visual Med, Inc.1998-07-31
UIBC (K982041)Abbott Laboratories1998-07-30
DIPSTREAK (K974428)Novamed , Ltd.1998-07-30
DIRECT HDL-CHOLESTROL LIQUID (K982341)Randox Laboratories, Ltd.1998-07-30
PYLORIPROBE (K981396)Amdl, Inc.1998-07-30
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM (K980821)Zeus Scientific, Inc.1998-07-30
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) (K981675)Besglove Medicare Sdn. Bhd.1998-07-28
POWDERED GREEN NITRILE EXAMINATION GLOVES (K981674)Besglove Medicare Sdn. Bhd.1998-07-28
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (K981673)Besglove Medicare Sdn. Bhd.1998-07-28
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K981774)Pwa Industries Sdn. Bhd.1998-07-24
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM (K981736)Organon Teknika Corp.1998-07-24
CARRIAZO BARRAQUER MICROKERATOME (K981741)Moria, Inc.1998-07-24
CARESIDE ANALYZER (K982118)Exigent Diagnostics, Inc.1998-07-24
SENSITEX EXAMINATION GLOVE (K981963)Oak Carolina, Inc.1998-07-24
ML MICROKERATOME (K981071)Med-Logics, Inc.1998-07-23
VIPERCAM (K981534)Integra Medical1998-07-23
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR (K981978)Pointe Scientific, Inc.,1998-07-22
TIBC (K981654)Abbott Laboratories1998-07-22
VCA IGM ELISA TEST SYSTEM (K980596)Clark Laboratories, Inc.1998-07-22
AMM (K981920)Abbott Laboratories1998-07-22
CHEM-CHEX STAT (NEW) (K982290)Streck Laboratories, Inc.1998-07-22
SUPERGLOVES POWDERED NITRILE (K980966)Supermax Sdn Bhd1998-07-22
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 (K981493)Polymer Technology Systems, Inc.1998-07-22
VCA IGG ELISA TEST SYSTEM (K980912)Clark Laboratories, Inc.1998-07-22
COLORPAC TOXIN A (K980185)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-07-17
OCULOSTAT (K981235)Laser Center Dev. Corp.1998-07-15
PAR-ONE (K981391)Remel, Inc.1998-07-14
C3 EXTERNAL MALE BLADDER CONTROL DEVICE (K974040)Timm Research Co.1998-07-14
CARESIDE HDL-CHOLESTEROL (K981899)Exigent Diagnostics, Inc.1998-07-14
VIGIL PROTEIN CONTROL (K982224)Beckman Coulter, Inc.1998-07-09
MYCYCLE, HANDMASTER, VICTORY (K981557)Richvale , Ltd.1998-07-09
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (K982210)Dade Behring, Inc.1998-07-09
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (K981579)ETHICON, Inc.1998-07-09
MYCYCLE HANDMASTER, LIGHT (K981558)Richvale , Ltd.1998-07-09
MONARCH IOL DELIVERY SYSTEM (K981571)Alcon Laboratories1998-07-09
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION (K981488)Oak Carolina, Inc.1998-07-07
VIGIL HEMOGLOBIN (HBALC) CONTROLS (K982022)Beckman Coulter, Inc.1998-07-06
ANSPACH SHIELDED ATTACHMENT (K974025)The Anspach Effort, Inc.1998-07-06
POREX NOSTRIL RETAINERS (K981374)Porex Surgical, Inc.1998-07-02
AC/AD LINEARITY VERIFIERS (K982217)Sc Calibrators & Controls, LLC1998-07-02
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 (K982024)Medical Analysis Systems, Inc.1998-06-29
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 (K981933)Medical Analysis Systems, Inc.1998-06-29
I-STAT LACTATE TEST (K982071)I-Stat Corp.1998-06-29
HICHEM PHOSPHORUS REAGENT KIT (K981769)Elan Pharma, Inc.1998-06-29
CHOL (K981652)Abbott Laboratories1998-06-29
THALAFIX NATURAL SEA SALT DRESSING (K980779)Dumex Medical Surgical Products, Ltd.1998-06-26
CARESIDE URIC ACID (K981604)Careside, Inc.1998-06-25
SPENCO SILICONE GEL SHEET (K981902)Spenco Medical Corp.1998-06-25
CARESIDE ANALYZER (K981610)Careside, Inc.1998-06-25
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE (K982009)Scitech Solutions, Inc.1998-06-25
CHOL (K981476)Abbott Laboratories1998-06-25
CLEARPLAN EASY OVULATION TEST (K981271)Unipath , Ltd.1998-06-25
SEMKIN BIPOLAR FORCEP (K974594)Titan Mfg., Inc.1998-06-24
CUSHING BAYONET, INSULATED BIPOLAR FORCEP (K974595)Titan Mfg., Inc.1998-06-24
SEMKIN INSULATED BIPOLAR FORCEP (K974593)Titan Mfg., Inc.1998-06-24
AUTOMATED CORNEAL TREPHINE (K981063)Laser Center Dev. Corp.1998-06-23
HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES (K981893)M.R.G. Industries Sdn. Bhd.1998-06-22
NITRILON CORRECT-TOUCH (K981333)Biopro (M) Sdn Bhd1998-06-22
NITRILON CORRECT-TOUCH (K981304)Ct Intl.1998-06-22
MRS-400, MAXI 400, MRSL-400, MAXI 400L (K981990)D.B.I. America Corp.1998-06-22
AMM (K981467)Abbott Laboratories1998-06-22
URIC ACID (K981766)Abbott Laboratories1998-06-19
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (K981053)Eastman Kodak Company1998-06-18
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (K974761)John O. Butler Co.1998-06-16
PHOS (K981759)Abbott Laboratories1998-06-16
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 (K981864)Beckman Coulter, Inc.1998-06-12
PHOS (K981118)Abbott Laboratories1998-06-12
QTEXX POWDERFREE LATEX EXAMINATION GLOVES (K981767)Latexx Partners Bhd.1998-06-11
HDL (K981580)Abbott Laboratories1998-06-11
TC SERIES (TRANSPORT) (K981418)Get A Life-Give A Living Plus Kids Project, Inc.1998-06-10
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON (K981590)Bio-Rad1998-06-10
STERILE, POWDERFREE LATEX EXAMINATION GLOVE (K980785)London Intl., LLC1998-06-10
TC SERIES (RECLINER) (K981421)Get A Life-Give A Living Plus Kids Project, Inc.1998-06-10
TC SERIES (K981422)Get A Life-Give A Living Plus Kids Project, Inc.1998-06-10
EVANESCE SCAR MANAGEMENT SYSTEM (K981387)Medical Scientific, Inc.1998-06-10
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER (K980047)Yeongdong Pharmaceutical Corp.1998-06-10
TC SERIES (WIDE) (K981420)Get A Life-Give A Living Plus Kids Project, Inc.1998-06-10
TC SERIES (TILT RECLINER) (K981419)Get A Life-Give A Living Plus Kids Project, Inc.1998-06-10
SUPERGLOVES (K980494)Supermax Sdn Bhd1998-06-09
CLEAR (TM) LICE EGG REMOVER SYSTEM (K981147)Care Technologies, Inc.1998-06-09
IRON (K981581)Abbott Laboratories1998-06-08
DADE TRU-LIQUID CARDIAC CONTROL (K981622)Dade Behring, Inc.1998-06-08
POWDERED NITRILE EXAMINATION GLOVES (K981133)Servicom Services Sdn Bhd1998-06-05
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (K980929)Ansell Perry1998-06-05
FLARE,FILE, FILL (K981234)Lone Star Technologies1998-06-05
MACH-SIGMA HANDPIECE, ULTRAPUSH (K980162)Nsk Nakanishi, Inc.1998-06-05
JPACS (K980918)Philips Medical Systems (Cleveland), Inc.1998-06-03
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES (K981062)Ideal Quality Sdn., Bhd.1998-06-01
DIASCREEN REAGENT STRIPS (K981555)Chronimed, Inc.1998-06-01
PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES (K981159)Latexx Partners Bhd.1998-06-01
LICEMEISTER COMB (K981250)National Pediculosis Assoc.1998-05-28
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING (K980989)Innovative Technologies , Ltd.1998-05-27
INTRAVASCULAR RETRIEVAL DEVICE (K981061)Med Institute, Inc.1998-05-26
CLEAR (TM) SPECIAL NIT COMB (K981037)Care Technologies, Inc.1998-05-22
DOWNSCAN LT (K974882)Merlin Engineering Works, Inc.1998-05-22
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