Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
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
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 (K913920)Em Diagnostic Systems, Inc.1991-09-27
MINNILERT(R) PRESSURE MONITOR (K913483)Minntech Corp.1991-09-27
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (K912838)Baxter Diagnostics, Inc.1991-09-27
CEDIA(R) GENTAMICIN ASSAY (K913470)Microgenics Corp.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
ENDOSCOPE SUTURE & CARRIER (K912973)United States Surgical, A Division of Tyco Healthc1991-09-27
MEGA SPINAL ANESTHESIA KIT (K912322)Mega Medical, Inc.1991-09-26
SARNS NON-FILTERED VENOUS RESERVOIR (K912915)3M Health Care, Ltd.1991-09-25
J&S IRON REAGENTS (K912716)J.S. Medical Assoc.1991-09-25
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET (K912932)Synthes (Usa)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
COHERENT HOLMIUM:YAG SURGICAL LASER (K910037)Coherent Medical Group1991-09-25
DESERT SHIELD SUNGLASSES (K912863)Command Marketing Corp.1991-09-25
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES (K912616)Technicon Instruments Corp.1991-09-25
INCARE HOT/ICE ABSORBENT INTERFACE (K913035)Hollister, Inc.1991-09-25
KODAK EKTACHEM DT SLIDES (LIPASE) (K913196)Eastman Kodak Company1991-09-25
WILTEK ELECTROCAUTERY ACTIVE CORD (K914132)Wiltek Medical, Inc.1991-09-25
CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO (K910027)Biovision, Inc.1991-09-25
QUANTIMETRIX AMMONIA CONTROLS (K913346)Quantimetrix Corp.1991-09-25
IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 (K912229)Dlp, Inc.1991-09-25
THE E TEST, MODIFICATION (K913459)Ab Biodisk1991-09-25
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
URINE AMPHETAMINE DIRECT RIA KIT (I-125) (K913866)Immunalysis Corporation1991-09-25
RAICHEM(TM) CREATINE KINASE-MB REAGENT (K913398)Reagents Applications, Inc.1991-09-25
WILTEK ELECTROCAUTERY ADAPTOR (K914131)Wiltek Medical, Inc.1991-09-25
HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER (K913918)Heraeus Lasersonics, Inc.1991-09-25
IV HOUSE (K912942)Progressive Iv'S, Inc.1991-09-25
ELEC SURG INSTR FOR LOPPROSCOPE CHOLECYSTECYOMY (K912968)Paden Foudry , Ltd.1991-09-25
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER (K912920)3M Health Care, Ltd.1991-09-25
EBNA STAT TEST KIT (K911473)Whittaker Bioproducts, Inc.1991-09-25
AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER (K913211)United States Surgical, A Division of Tyco Healthc1991-09-25
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL (K913792)Hichem Diagnostics1991-09-25
CHERRY SPONGE (K913500)O.R. Concepts, Inc.1991-09-25
B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES (K913902)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-09-25
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (K913414)Roche Diagnostic Systems, Inc.1991-09-25
FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N- (K912861)Biocor, Inc.1991-09-24
JAMIESON JT-CRP CINE FILM PROCESSOR (K913241)Jamieson Film Co.1991-09-24
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (K912843)Flexmedics1991-09-24
CARDIOTRACE CARDIAC EVALUATION SYSTEMS (K912829)Cine Graphics, Inc.1991-09-24
UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR (K912552)Personal Products Co.1991-09-24
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER (K910536)Mill-Rose Laboratory1991-09-24
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES (K911580)Exmoor Plastics , Ltd.1991-09-24
OPTICAL CATHETER ARTHROSCOPE (K911296)Medical Dynamics, Inc.1991-09-24
LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET (K913078)Norland Corp.1991-09-24
G-PIN (K911375)Dr.M.A.Galluzzo1991-09-23
CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY (K912833)Camino Laboratories, Inc.1991-09-23
HEMATASTAT C-70B (K913128)Separation Technology, Inc.1991-09-23
LIFECARE CPAP-100 (K912224)Lifecare Services, Inc.1991-09-23
INNOFLUOR(TM) DIGITOXIN REAGENT SET (K913187)Intl. Bioclinical, Inc.1991-09-23
ANTI-JO-1 MICROASSAY (K911679)Diamedix Corp.1991-09-23
PROFUSE INFUSION SYSTEM (K912877)Lake Region Mfg., Inc.1991-09-23
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY (K913234)Varian Canada, Inc.1991-09-23
AMPLANTZ AND BENTSON GUIDEWIRES (K912798)Meadox Medicals, Div. Boston Scientific Corp.1991-09-23
BIPURE 1000 (K912347)Laser Engineering, Inc.1991-09-23
MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM) (K911604)Medphone Corp.1991-09-23
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION (K913201)Oscor Medical Corp.1991-09-23
IMPLANT PACING LEAD TINED #3390, MODIFICATION (K913203)Oscor Medical Corp.1991-09-23
NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (K911784)North American Sterilization & Packaging Co.1991-09-23
3 PORT ADAPTER (K913627)Baxter Healthcare Corp1991-09-23
RIGHT ATRIAL CATHETERS (K911333)Akcess Medical Products, Inc.1991-09-23
CARDIOSWISS CM-8 (K910109)Care Systems, Inc.1991-09-23
IMAC2000 (K911764)Medical Imaging Technologies, Inc.1991-09-23
BACTIDROP(TM) VOGES-PROSKAUER B (K913007)Remel Co.1991-09-23
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE (K912972)Abbott Laboratories1991-09-23
BACTIDROP(TM) FERRIC CHLORIDE (10%) (K913002)Remel Co.1991-09-23
STARPAC O.R. TOWEL (K912947)Multi M Intl., Inc.1991-09-23
ALWAYS, UNSCENTED MENSTRUAL PAD (K913238)Procter & Gamble Co.1991-09-23
PROBE LATEX EXAMINATION GLOVES - STERILE (K912392)Glovetex Industries1991-09-23
OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF (K913205)Oscor Medical Corp.1991-09-23
LATEX EXAMINATION GLOVES (K913279)Liwe Trading1991-09-23
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION (K913204)Oscor Medical Corp.1991-09-23
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B (K912749)Medical Analysis Systems, Inc.1991-09-23
BODEN WHEELCHAIR DRAINAGE SYSTEM (K913142)Mno Medical Products1991-09-23
BACTIDROP(TM) DOBELL & O'CONNOR IODINE (K913006)Remel Co.1991-09-23
IMPLANT PACING LEAD, TINED #3262, MODIFICATION (K913202)Oscor Medical Corp.1991-09-23
BACTIDROP(TM) OXIDASE (K913008)Remel Co.1991-09-23
XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL (K912753)Xomed-Treace, Inc.1991-09-23
CHOLANGIOGRAPHY CATHETER (K912122)Wiltek Medical, Inc.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
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION (K913393)Oscor Medical Corp.1991-09-23
BIOMERIEUX RSV DIRECT IF KIT (K912371)Vitek Systems, Inc.1991-09-23
SEVACARE STERILE SURGEON'S GLOVES (K912478)Sevaids Industries1991-09-23
VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS (K910111)Instrumentarium Imaging, Inc.1991-09-23
MECHANICAL SHAPE SENSOR (K913510)Pin Dot Products, Inc.1991-09-23
ANTI-DNA MICROASSAY (K912020)Diamedix Corp.1991-09-23
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT (K905709)Beckman Instruments, Inc.1991-09-23
ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM (K912420)Scientific Research1991-09-23
QTEST INFLUENZA A (K913828)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-09-23
MODIFIED OSCOR PY PACING LEADS/MODIFICATION (K913158)Oscor Medical Corp.1991-09-23
TRAC-WRIGHT SYSTEM, MODEL TW2 (K910594)Dow Corning Wright1991-09-23
ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (K913237)Procter & Gamble Co.1991-09-23
WILTEK STANDARD CHOLANGIOGRAPHY CATHETER (K912288)Wiltek Medical, Inc.1991-09-23
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.