Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM (K993125)Safety Medical Supply Int,., Inc.2000-06-20
BREAST IMMOBILIZATION DEVICE MR-BY 160 (K001303)Mri Devices Corp.2000-06-20
MEDI-CULT HYALURONIDASE; (K991334)Medicult A/S2000-06-20
OCD2001 (K992935)Contemporary Products, Inc.2000-06-20
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 (K001286)Diagnostic Chemicals , Ltd.2000-06-20
CALCIUM SULFATE PELLETS (K001559)Howmedica Osteonics Corp.2000-06-20
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES (K001733)Zimmer, Inc.2000-06-20
DADE BEHRING COAGULATION ANALYZER (BCT) (K001067)Dade Behring, Inc.2000-06-20
SIGNUM (K001360)J.F. Jelenko & Co., Inc.2000-06-20
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (K001632)Avl Scientific Corp.2000-06-19
PC COATED FLUOROPLASTIC VENT TUBES (K000801)Gyrus Ent LLC2000-06-19
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM (K994239)Medtronic Sofamor Danek, Inc.2000-06-19
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM (K001737)Lacrimedics, Inc.2000-06-19
ADVANTAGE THC TEST (K001567)Advantage Diagnostics Corp.2000-06-19
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (K000754)Quantase , Ltd.2000-06-19
CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 (K001484)Alko Diagnostic Corp.2000-06-19
CHAD THERAPEUTICS OXYMATIC MODEL 401 (K000890)Chad Therapeutics, Inc.2000-06-16
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES (K000892)Datex-Ohmeda, Inc.2000-06-16
PLACER MODEL 6232 STEERABLE STYLET (K000955)Medtronic Vascular2000-06-16
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET (K000433)Medical Device Technologies, Inc.2000-06-16
CONTEMPRO-MIST (K000543)Contemporary Products, Inc.2000-06-16
DYNA-LOK CLASSIC SPINAL SYSTEM (K001532)Medtronic Sofamor Danek, Inc.2000-06-16
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS (K000972)Synthes (Usa)2000-06-16
ABSOLUTE HCG PREGNANCY TEST (K000844)Mizuho USA, Inc.2000-06-16
ECHOCOM, IMAGECOM, DOKUCOM (K001592)Tomtec Imaging Systems GmbH2000-06-16
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 (K001463)Davis Schottlander & Davis, Ltd.2000-06-16
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (K000996)Dentsply Intl.2000-06-16
TEARAWAY INTRODUCER SHEATH (K000313)Xentek Medical, Inc.2000-06-16
ULTRASTIM ELECTRODE, MODEL US4040 (K000947)Axelgaard Mfg. Co., Ltd.2000-06-16
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 (K001082)Stackhouse, Inc.2000-06-15
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP (K001039)Implex Corp.2000-06-15
TRANS FX ADJUSTABLE PIN TO BAR CLAMP (K001084)Immedica, Inc.2000-06-15
STERRAD 100S STERILIZER (K991999)Advanced Sterilization Products2000-06-15
PIPET CURET (K001545)Milex Products, Inc.2000-06-15
MACH 7 (K990060)Kreativ, Inc.2000-06-15
NBS CONNECTING TUBE SET (K001068)Nbs Products CO2000-06-14
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA (K001713)Mri Devices Corp.2000-06-14
THERMAL CAUTERY FORCEPS (K001262)Starion Instruments2000-06-14
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC (K001112)General Electric Medical Systems Information Techn2000-06-14
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP (K001273)Starion Instruments2000-06-14
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL (K001593)Chester Labs, Inc.2000-06-14
MALLORY HEAD MODULAR CALCAR (K001660)Biomet Orthopedics, Inc.2000-06-14
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP (K994209)Cobe Cardiovascular, Inc.2000-06-14
MICROPERFORATION INSTRUMENT (K001507)Smith & Nephew, Inc.2000-06-14
AC POWERED THERMAL CAUTERY UNIT (K000893)Starion Instruments2000-06-14
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES (K001485)Pwa Industries Sdn. Bhd.2000-06-13
HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 (K001309)Kay See Dental Mfg. Co.2000-06-13
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR (K001475)Pwa Industries Sdn. Bhd.2000-06-13
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON (K001326)Ocular Concepts, LLC2000-06-13
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX (K000981)C-Mix2000-06-13
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM (K001762)Pulsion Medical Systems, Inc.2000-06-13
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING (K992532)Baxter Healthcare Corp2000-06-13
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN (K001620)Metro Optics of Austin, Inc.2000-06-13
SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 (K000627)Vitrolife AB/Scandinavian Ivf Sciences AB2000-06-13
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT (K001584)Medvice Consulting, Inc.2000-06-13
DIGITAL INTEGRATION SYSTEM, DIS2000 (K001012)Wellington Medical Systems, Inc.2000-06-13
IVC THREE BLASTOCYST MEDIUM, CAT # 2007 (K001113)Invitrocare, Inc.2000-06-13
EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION (K000237)Cybercare, Inc.2000-06-13
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM (K001284)Medtronic Surgical Navigation Technologies2000-06-12
3.5 MM LAPAROSCOPE (LG100, LG103) (K001594)Surgical Image Laboratories, Inc.2000-06-12
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (K993335)Synthes (Usa)2000-06-12
EUDERMIC PF POWDER-FREE SURGICAL GLOVES (K001343)Maxxim Medical, Inc.2000-06-12
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE) (K001549)Shanghai Poseidon Plastic Products Co., Ltd.2000-06-12
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 (K001252)Maxhealth Corp.2000-06-12
PINNACLE ACETABULAR SYSTEM (K001534)DePuy Orthopaedics, Inc.2000-06-12
DORNIER MEDILAS D SKINPULSE (K000072)Dornier Surgical Products, Inc.2000-06-12
'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE (K001434)Genzyme Surgical Product (Genzyme Biosurgery)2000-06-12
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL (K993518)Medefil, Inc.2000-06-12
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (K000687)Beacon Biologicals, Inc.2000-06-12
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA (K001529)Perusahaan Getah Asas Sdn. Bhd.2000-06-12
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 (K001574)Axis-Shield2000-06-09
CEDIA DAU 6-ACETYLMORPHINE ASSAY (K001178)Microgenics Corp.2000-06-09
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) (K001557)Kossan Latex Industries(M)Sdn Bhd2000-06-09
PHARMASEED, MODEL BT-125-2 (K993701)Syncor International, Inc.2000-06-09
TERUMO U-100 INSULIN SYRING (K001474)Terumo Medical Corp.2000-06-09
DELFIA NEONATAL IRT KIT (K993697)Wallac OY2000-06-09
3M QUIK TEMP TEMPORIZATION MATERIAL (K001114)3M Company2000-06-09
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES (K000377)Masif Healthcare Products Sdn. Bhd.2000-06-09
HI-RES 9000 PHASED ARRAY CAROTID COIL (K001210)Usa Instruments, Inc.2000-06-09
MICRO-FRANCE TROCARS AND ACCESSORIES (K993653)Xomed, Inc.2000-06-09
MODEL APS ALTERNANS PROCESSING SYSTEM (K001034)Cambridge Heart, Inc.2000-06-09
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML (K001287)Sorenson Medical, Inc.2000-06-09
SYNERGY HEAD/NECK COIL (K001331)Philips Medical Systems North America, Inc.2000-06-09
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR (K994199)Custom Medical Products, Inc.2000-06-09
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (K000336)Rhigene, Inc.2000-06-09
NARKOMED MRI , NM-MRI (K001488)Draeger Medical, Inc.2000-06-09
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE (K993316)Ueda Avancer Corp.2000-06-09
MULTI ADJUSTABLE FACE MASK (K000358)Ortho Technology2000-06-09
SPERMICIDAL LUBRICATED MALE LATEX CONDOM (K001377)Pleasure Latex Products Sdn. Bhd.2000-06-08
AU5 ULTRASOUND IMAGING SYSTEM (K000931)Biosound Esaote, Inc.2000-06-08
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER (K991137)Minntech Corp.2000-06-08
PENADAPT 10 (K000904)Buffalo Filter Co., Inc.2000-06-08
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) (K001602)Dideco S.P.A.2000-06-08
ENGAGE JAW INSERTS (K992980)Novare Surgical Systems, Inc.2000-06-08
TRI-BALL (K994074)Leventon, S.A.2000-06-08
AIRDENT II CS (K001313)Air Technologies, Inc.2000-06-08
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS (K001046)Biopro, Inc.2000-06-08
OMEGA II MODULAR TOTAL HIP SYSTEM (K000817)Osteoimplant Technology, Inc.2000-06-08
SPERM WASH MEDIUM, CAT# 2003/2005 (K000989)Invitrocare, Inc.2000-06-08
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM (K000842)Sims Deltec, Inc.2000-06-08
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