Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 (K022138)Spectranetics Corp.2002-09-23
TUBING, DIALYSATE (AND CONNECTOR) (K022068)Molded Products, Inc.2002-09-23
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS (K022287)3t Medical Systems, LLC2002-09-23
PLUS PIVOT LINK UNIVERSAL SYSTEM (K022271)Spine Vision, Inc.2002-09-23
NAFD 100 (K020848)Neomatrix, LLC2002-09-23
ORTHOGUARD AB ANTIMICROBIAL SLEEVE (K022676)Smith & Nephew, Inc.2002-09-23
TWIN FIX (K022771)Fixano SA2002-09-23
TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D (K020851)C&H International2002-09-23
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR (K022220)Shen Wei (Usa), Inc.2002-09-23
FERTILITE OV (K020808)Pheromone Sciences Corp.2002-09-23
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) (K021864)Primeline Medical Products, Inc.2002-09-23
RESTORATION MODULAR SYSTEM (K022549)Howmedica Osteonics Corp.2002-09-23
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A (K013974)Trimedyne, Inc.2002-09-23
STOCKERT CENTRIFUGAL PUMP CONSOLE (K020571)Stockert Instrumente GmbH2002-09-23
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED (K021740)Dj Orthopedics, LLC2002-09-23
SIGN IM NAIL (K022632)Surgical Implant Generation Network (Sign)2002-09-23
MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY (K022879)Sanarus Medical, Inc.2002-09-23
HIP TOOL IMPLANT (K022139)Orthopedic Sciences, Inc.2002-09-23
CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 (K022725)Good Biotech Corp.2002-09-23
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA (K021648)Inova Diagnostics, Inc.2002-09-20
SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S (K022099)Hdc Corp.2002-09-20
SQA V, SPERM QUALITY ANALYZER (K021746)Medical Electronic Systems, LLC2002-09-20
CHASE CARDIOVASCULAR PATCH KIT (K022093)Chase Medical, Inc.2002-09-20
PRECISEPLAN 2.0 (K022411)Precision Therapy Intl., Inc.2002-09-20
SOAKER CATHETER (K022869)I-Flow Corp.2002-09-20
CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER (K022061)Cryo Vascular Systems, Inc.2002-09-20
POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM (K022912)Basic Dental Implant Systems, Inc.2002-09-20
GE QUASAR NUCLEAR MEDICINE SYSTEM (K022960)Ge Medical Systems F.I. Haifa2002-09-19
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K022132)Siemens Medical Solutions USA, Inc.2002-09-19
CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC (K022387)Craftmatic Organization, Inc.2002-09-19
3I DENTAL IMPLANT ACCESSORIES (K022113)Implant Innovations, Inc.2002-09-19
DVT60 (K022786)Huntleigh Healthcare, Inc.2002-09-19
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) (K022363)St. Jude Medical, Inc.2002-09-19
SMART BREATH RESPIRATORY COMPENSATION OPTION (K022919)GE Medical Systems2002-09-19
DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 (K022075)Cp Medical2002-09-19
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM (K022859)Straumann USA2002-09-19
MY ALLERGY TEST (K021698)Immunetech Corporation2002-09-19
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK (K021646)Binax, Inc.2002-09-19
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES (K022318)Vomed Volzer Medizintechnik GmbH & Co.2002-09-19
NATUS BLUE LIGHT PHOTOTHERAPY UNIT (K022196)Natus Medical, Inc.2002-09-19
STERNGOLD 1, MODEL 1127781 (K022252)Sterngold2002-09-19
DUOPRO SAFETY SYRINGE (DUOPROSS) (K022806)M.K. Meditech Co. , Ltd.2002-09-19
PUMP TUBING WITH X-COATING (K022857)Terumo Cardiovascular Systems Corporation2002-09-19
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK (K021649)Binax, Inc.2002-09-19
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K022744)Medical Device Services2002-09-18
BIOPORTA SOLDER 1020 (K022462)Wieland Dental + Technik GmbH & Co. KG2002-09-18
STERILOX LIQUID CHEMICAL STERILANT SYSTEM (K013280)Sterilox Technologies, Inc.2002-09-18
PORTA SOLDER 1080 W (K022470)Wieland Dental + Technik GmbH & Co. KG2002-09-18
MODIFICATION TO TSRH SPINAL SYSTEM (K022778)Medtronic Sofamor Danek, Inc.2002-09-18
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM (K022224)Coltene AG2002-09-18
ECO E4 (K022469)Wieland Dental + Technik GmbH & Co. KG2002-09-18
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 (K020581)Medical Concepts Development, Inc.2002-09-18
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 (K020255)Richard Wolf Medical Instruments Corp.2002-09-18
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 (K022163)Welch Allyn, Inc.2002-09-17
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (K022772)Hemagen Diagnostics, Inc.2002-09-17
PORTA OPTIMUM SOLDER 900 (K022468)Wieland Dental + Technik GmbH & Co. KG2002-09-17
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA (K022444)Wrp Asia Pacific Sdn. Bhd.2002-09-17
GEN-PROBE APTIMA COMBO 2 ASSAY (K022874)Gen-Probe, Inc.2002-09-17
PORTA IP SOLDER V-1 (K022456)Wieland Dental + Technik GmbH & Co. KG2002-09-17
BIOMET CALCANEAL PLATE (K022515)Biomet Orthopedics, Inc.2002-09-17
PREMIER ANTERIOR CERVICAL PLATE SYSTEM (K021761)Medtronic Sofamor Danek2002-09-17
EXTERNAL FIXATION RING (K022423)Rigid FX Orthopedics, Incorporated2002-09-17
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 (K022991)Bio-Rad2002-09-17
PORTA IP SOLDER V-2 (K022467)Wieland Dental + Technik GmbH & Co. KG2002-09-17
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (K021057)Brahms Diagnostica, LLC2002-09-17
M2376A DEVICELINK SYSTEM (K022920)Philips Medical Systems2002-09-17
POCKETCHEM UA AUTION STICKS 10TA (K022386)Arkray, Inc.2002-09-17
IMPERIUM (K022114)Elmstech, Inc.2002-09-17
BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) (K022878)Brightway Holdings Sdn. Bhd.2002-09-17
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER (K022758)Cliniqa Corporation2002-09-17
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM (K022324)Osteomedics, Inc.2002-09-17
PORTA OPTIMUM SOLDER 710 (K022457)Wieland Dental + Technik GmbH & Co. KG2002-09-17
MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR (K022818)Smart Glove Corp. Sdn Bhd2002-09-17
SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 (K020464)Rolor Electronics Corp.2002-09-17
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E (K022701)Perusahaan Getah Asas Sdn. Bhd.2002-09-17
OEC FLUOROTRAK 9800 PLUS (K022069)Ge Oec Medical Systems2002-09-17
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (K020583)Ivd Research, Inc.2002-09-17
POWDERED SYNTHETIC VINYL EXAM GLOVES (K022702)Shijiazhuang Holy Plastics Co., Ltd.2002-09-16
SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES (K022639)Shijiazhuang Holy Plastics Co., Ltd.2002-09-16
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES (K022600)Shijiazhuang Wally Plastics Co., Ltd.2002-09-16
MODIFICATION TO PLAYTEX TAMPONS #24002 (K022882)Playtex Products, Inc.2002-09-16
ULTI GUARD HOME INSULIN SYRINGE CONTAINER (K021983)Ultimed, Inc.2002-09-16
SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 (K020462)Rolor Electronics Corp.2002-09-16
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS) (K022343)Pt. Wrp Buana Multicorpora2002-09-16
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK (K021687)Binax, Inc.2002-09-13
PTA AND PTV (K022722)NuMED, Inc.2002-09-13
URETERAL ACCESS SHEATH SET (UASS) (K022135)Boston Scientific Corp2002-09-13
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR (K022699)Forever Young Ent. Co., Ltd.2002-09-13
DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 (K014141)Digibio Technology Corp.2002-09-13
CONDUCTIVE GEL (K022006)The Dezac Group2002-09-13
TOTAL BILIRUBIN (K022339)Abbott Laboratories2002-09-13
AB BELT (K020427)The Dezac Group2002-09-13
RSV OIA (K021172)Thermo Biostar, Inc.2002-09-13
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM (K022231)Osteomedics, Inc.2002-09-13
COMFY HIGH RISER WHEELCHAIR (K022617)Lenjoy Medical Engineering, Inc.2002-09-13
TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 (K022003)Micro Therapeutics, Inc.2002-09-13
AGILTRAC .035 PERIPHERAL DILATATION CATHETER (K022738)Guidant Corp.2002-09-13
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 (K022880)Guidant Corp.2002-09-13
AB BELT PRO (K020429)The Dezac Group2002-09-13
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (K021989)Integra Neurosciences2002-09-13
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