Atlas FDA

2000

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

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RecordFirmDate
GE LOGIQ 700 (K000516)Ge Medical Systems, Inc.2000-04-19
GETTIG GUARD (K000455)Gettig Pharmaceutical Instrument Co.2000-04-19
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES (K000205)Rocket Medical Plc2000-04-19
BIOCERAMIC ORBITAL IMPLANT (K992294)Fci Ophthalmics, Inc.2000-04-19
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 (K000874)Bio-Rad2000-04-18
QUIK-CAP (K000865)Neuroscan2000-04-18
CSM STRETTA SYSTEM (K000245)Conway Stuart Medical, Inc.2000-04-18
PARA 12 PLUS RETICS (K000945)Streck Laboratories, Inc.2000-04-18
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST (K000400)Drug Detection Devices, Ltd.2000-04-18
MODIFICATION TO TSRH SPINAL SYSTEM (K000991)Medtronic Sofamor Danek, Inc.2000-04-18
NUVASIVE TOWNLEY FACET SCREW (K994308)Nuvasive, Inc.2000-04-18
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER (K001154)I-Stat Corp.2000-04-18
MEDTRADE PRODUCTS ALGINATE ISLAND (K000487)Medtrade Products , Ltd.2000-04-18
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES (K000106)Fotona D.D.2000-04-18
THERMOFLEX SYSTEM (K000508)Argomed, Inc.2000-04-18
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST (K000402)Drug Detection Devices, Ltd.2000-04-18
GE LOGIQ 700 (K000571)GE Medical Systems2000-04-18
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP (K000876)Interpore Cross Intl.2000-04-18
PM 2002 PROLINE/AEC (K000163)Planmeca Oy2000-04-18
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST (K000522)Drug Detection Devices, Ltd.2000-04-18
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 (K000398)Shield Diagnostics, Ltd.2000-04-17
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (K991908)Idemsa2000-04-17
STAT PROFILE PHOX PLUS ANALYZER (K000895)Nova Biomedical Corp.2000-04-17
FLUROPERM 60-OK, PARAGON HDS-OK (K000224)Paragon Vision Sciences2000-04-17
SPIFE CHOLESTEROL PROFILE KIT (K000603)Helena Laboratories2000-04-17
WILSON-COOK COLONIC Z-STENT (K990034)Med Institute, Inc.2000-04-17
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT (K993677)Medtronic Vascular2000-04-17
ENHANCED COMPENSATING FILTER (K000137)Computerized Medical Systems, Inc.2000-04-17
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 (K991818)Acrymed, Inc.2000-04-17
SUTUREGROOVE (K994289)Iop, Inc.2000-04-17
DRG AURICA ELISA TESTOSTERONE KIT (K000043)Drg Intl., Inc.2000-04-17
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A (K000458)Dade Behring, Inc.2000-04-17
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE (K000406)Rhino Metrics A/S2000-04-17
MEDLINE TENDER WET WOUND DRESSING (K991755)Medline Industries, Inc.2000-04-17
CHILI VIDEO, CHILI VIDEOPRO (K000411)Steinbeis-Transferzentrum Medizinische Informatik2000-04-14
APPRAISE-CARDIO SAMPLE COLLECTION KIT (K993787)Osborn Group, Inc.2000-04-14
HAIDER-UCR SPINAL SYSTEM (K993503)International Advanced Medical Enterprises, Inc.2000-04-14
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A (K000467)Dade Behring, Inc.2000-04-14
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K991519)Ameriwater2000-04-14
SONADA ULTRASOUND SYSTEM (K993092)Sonovision Corp.2000-04-14
INTERVENTIONAL BODY COIL (K000437)Usa Instruments, Inc.2000-04-14
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS (K993489)Crystal Reflections, Int., Inc.2000-04-14
LAZERSMILE, LAZERWHITE (K000290)Biolase Technology, Inc.2000-04-14
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE (K000971)Wrp Asia Pacific Sdn. Bhd.2000-04-14
AGILITY STEERABLE GUIDEWIRE (K001033)Cordis Neurovascular, Inc.2000-04-14
TENAX WHITE POST (K993545)Coltene/Whaledent, Inc.2000-04-14
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT (K000494)Beckman Coulter, Inc.2000-04-14
MODIFICATION TO EBI SPINELINK SYSTEM (K001037)Ebi, L.P.2000-04-14
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A (K000464)Dade Behring, Inc.2000-04-14
INTRASTENT DOUBLESTRUT XS STENT (K000864)Intratherapeutics, Inc.2000-04-14
ABC CERVICAL PLATING SYSTEM (K000486)Aesculap, Inc.2000-04-14
EZ CONNECT (K000346)Kerr Dental Materials Center2000-04-14
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA (K000126)Masimo Corp.2000-04-14
PRODIGY LATERAL VIEW SOFTWARE (K000826)Lunar Corp.2000-04-14
939UDX URINE PATHOLOGY SYSTEM (K000373)Intl. Remote Imaging Systems2000-04-14
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (K000238)Mrl Diagnostics2000-04-14
MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 (K000911)Hysterx, Inc.2000-04-14
EEG WITH VIDEO, MODEL EX-NW (K000898)Excel Tech. , Ltd.2000-04-14
SYNTHES (USA) WRIST FUSION PLATES (WFP) (K000558)Synthes (Usa)2000-04-14
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE (K000223)Phoenix Medical Technology, Inc.2000-04-14
FIXATION STYLETS, MODELS 335-287 AND 335-288 (K000366)Accufix Research Institute2000-04-14
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR (K000241)Radiotherapeutics Corp.2000-04-14
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A (K000460)Dade Behring, Inc.2000-04-14
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA (K000570)Boston Scientific Corp2000-04-13
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 (K994164)Roche Diagnostics Corp.2000-04-13
CORTEK MINI LAPAROSCOPE (K000199)Cortek Endoscopy, Inc.2000-04-13
RANDOX PREALBUMIN (K000661)Randox Laboratories, Ltd.2000-04-13
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 (K000206)Axelgaard Mfg. Co., Ltd.2000-04-13
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 (K994240)Biotronik, Inc.2000-04-13
LIGA-LOOP SUTURE APPLICATOR (K993695)Hysterx, Inc.2000-04-13
CTC DVT-1 CALF GARMENT, MODEL DVT-1 (K000147)Compression Therapy Concepts, Inc.2000-04-13
HARDYDISK, CEPHALOTHIN 30MCG (K000526)Hardy Diagnostics2000-04-13
GATIFLOXACIN, 5 UG, BBL SENSI-DISC (K000829)Bd Becton Dickinson Vacutainer Systems Preanalytic2000-04-13
ACTIVATOR PASTE (K994027)Harry J. Bosworth Co.2000-04-13
BAYER PSA ASSAY (K994221)Bayer Corp.2000-04-13
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX (K000824)Medamicus, Inc.2000-04-13
LEMAITRE OCCLUSION CATHETER (K992942)Vascutech, Inc.2000-04-13
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 (K000112)Dentsply Intl.2000-04-13
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) (K000168)Datex-Ohmeda2000-04-13
TFX MEDICAL STYLET CATHETER (K992664)Tfx Medical Group2000-04-13
QUALITROL LIPID CONTROL, LEVELS 1 AND 2 (K000810)Consolidated Technologies of Wisconsin2000-04-13
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) (K993608)Datex-Ohmeda, Inc.2000-04-13
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE (K000117)Avid Medical, Inc.2000-04-13
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE (K000646)Enteric Medical Technologies2000-04-13
IQ CHAMBERS (K992553)Dormer Laboratories, Inc.2000-04-12
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000584)Shasta Asia Partners Gloves Manufacturing CO , Ltd.2000-04-12
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER (K000793)Guidant Corp.2000-04-12
JET PORT PLUS CATHETER SYSTEM (K000125)Clinical Plastic Products SA2000-04-12
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S (K000740)Asahi Iryoki Co., Ltd.2000-04-12
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), (K000105)Medtronic Vascular2000-04-12
INCENTIVE SPIROMETER (K000314)Engineered Medical Systems2000-04-12
MTP DISPOSABLE TROCAR VALVES (K000337)Mtp Medical Technical Promotion GmbH2000-04-12
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 (K001008)Oriental System Technology, Inc.2000-04-12
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 (K000127)Heinz Kurz GmbH Medizintechnik2000-04-12
GSI 2000 MIDDLE EAR ANALYZER (K000097)Grason-Stadler, Inc.2000-04-12
SOFTLINE SPRING CLIP (K000098)Novare Surgical Systems, Inc.2000-04-12
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER (K993116)A&D Engineering, Inc.2000-04-12
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES (K000688)N.S. Uni-Gloves Sdn. Bhd.2000-04-12
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED (K994099)Evergreen Medical Produts (Jingxing) Co., Ltd.2000-04-12
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA (K000275)Datex-Ohmeda, Inc.2000-04-12
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