Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
IRRIGATION OR INFUSION PUMP K PUMP (K991203)Kmi Kolster Methods, Inc.1999-10-15
DAIWA MODEL 180 (K983616)Daiwa Products, Inc.1999-10-15
MODIFICATION TO INTRASTENT (K992816)Intratherapeutics, Inc.1999-10-15
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (K992435)Azo Enterprises1999-10-15
QSC-085 SHOULDER ARRAY COIL (K993279)Mri Devices Corp.1999-10-15
FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER (K990401)Fukuda Denshi USA, Inc.1999-10-15
SURGITRON RADIOLASE (K992382)Ellman Intl., Inc.1999-10-14
ECOMED SCALP VEIN SET (K992145)Greiner Meditech, Inc.1999-10-14
PASCO MIC AND MIC/ID PANELS, CEFOTAXIME (K992568)Pasco Laboratories, Inc.1999-10-14
PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL (K992593)Pasco Laboratories, Inc.1999-10-14
NEUROFAX, MODEL EEG-1100A (K992742)Nihon Kohden America, Inc.1999-10-14
ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- (K992769)Erbe USA, Inc.1999-10-14
RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG (K992484)Jordco, Inc.1999-10-14
CONTOUR SPINAL SYSTEM (K990986)Ortho Development Corp.1999-10-14
HICHEM BUN REAGENT (K992847)Elan Holdings, Inc.1999-10-14
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY (K990372)Dr. Fritz GmbH1999-10-14
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 (K992458)Innovasive Devices, Inc.1999-10-14
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992555)Shijiazhuang Great Vision Plastic Products Co., LT1999-10-14
SIMPLICARE TRANSPARENT WOUND DRESSING (K991214)Hollister, Inc.1999-10-14
ZIPPY (K983808)Pillar Technology, Inc.1999-10-14
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232 (K992612)Ethicon Endo-Surgery, Inc.1999-10-14
ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 (K992764)Erbe USA, Inc.1999-10-14
GLUMA COMFORT BOND (K992985)Heraeus Kulzer, Inc.1999-10-14
MAXIM KNEE SYSTEM (K993159)Biomet, Inc.1999-10-14
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER (K993089)Deroyal Cardiovascular, Inc.1999-10-14
CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 (K993002)Ceram Optec, Inc.1999-10-14
VIDEO PLUS SYSTEM, SERIES 95000 (K992666)Camtronics, Ltd.1999-10-13
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22 (K992369)Interpore Cross Intl.1999-10-13
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K992768)Ansell Perry1999-10-13
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE (K992865)Maxxim Medical1999-10-13
RAYPAX WEB CLINICAL SYSTEM (K992426)Samsung Sds Co., Ltd.1999-10-13
ENDO-EZE MOTOR AND HANDPIECE (K992380)Ultradent Products, Inc.1999-10-13
URETERO-RENOSCOPE (K992527)Fiber Imaging Technologies, Inc.1999-10-13
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991205)Allegiance Healthcare Corp.1999-10-13
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C (K991563)Henke Sass Wolf of America, Inc.1999-10-13
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 (K992547)Canon USA, Inc.1999-10-13
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE (K992562)Pasco Laboratories, Inc.1999-10-13
NEO-2 METER (K992431)Automata Instrumentation, Inc.1999-10-13
THE LEADAWAY (K992372)Therapy Equipment, Inc.1999-10-13
SNT IMAGE ANALYSIS SYSTEM (K992354)Surgical Navigation Technologies, Inc.1999-10-12
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES (K992360)Tg Medical Sdn. Bhd.1999-10-12
VISTA BRITE TIP CATHETERS (K992673)Cordis Corp.1999-10-12
PASCO MIC AND MIC/ID PANELS, MEROPENEM (K992546)Pasco Laboratories, Inc.1999-10-12
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 (K992056)Sulzer Carbomedics, Inc.1999-10-12
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING (K992334)Implant Innovations, Inc.1999-10-08
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI (K993088)Puritan Bennett Corp.1999-10-08
PERMOBIL POWERED WHEELCHAIR 1280 (K991658)Permobil AB1999-10-08
3M CLINPRO SEALANT (K992326)3M Company1999-10-08
MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) (K992238)Masimo Corp.1999-10-08
AIRIS, AIRIS II (K992650)Hitachi Medical Systems America, Inc.1999-10-08
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 (K993098)Data Medical Associates, Inc.1999-10-08
VIRGO MRI SYSTEM (K990153)Millennium Technology Services1999-10-08
ACON COMBO PREGNANCY (K993065)ACON Laboratories, Inc.1999-10-08
ETCO2 VITAL SIGNS MODULE (K983864)Mennen Medical, Inc.1999-10-08
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM (K993077)Howmedica Osteonics Corp.1999-10-08
CIDEX OPA SOLUTION (K991487)Advanced Sterilization Products1999-10-08
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS (K992347)Cordis Corp.1999-10-08
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE (K992340)Masimo Corp.1999-10-08
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN (K992507)Pasco Laboratories, Inc.1999-10-08
RC TACK (K992377)Innovasive Devices, Inc.1999-10-08
BROWNE CIDEX OPA INDICATOR (K991709)Albert Browne , Ltd.1999-10-08
EBI OMEGA 21 SYSTEM (K992333)Electro-Biology, Inc.1999-10-08
TECHNOSANAT KRYO TSK 2005 (K992536)Technosanat Innovative Medizintechnik GmbH1999-10-08
QUANTEC-E IRRIGATION SYSTEM 2 (K992195)Sybron Dental Specialties, Inc.1999-10-08
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK (K992366)Ortho-Clinical Diagnostics, Inc.1999-10-08
SEALOUETTE FIBRIN SEALANT APPLICATOR (K992351)Biosurgical Corp.1999-10-08
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM (K992319)Guidant Corp.1999-10-08
VIEWPOINT ENT/ORTHOPEDIC OPTION (K991256)Philips Medical Systems (Cleveland), Inc.1999-10-08
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ (K992409)Implex Corp.1999-10-08
MODIFICATION TO BONE MULCH SCREW SYSTEM (K993025)Biomet, Inc.1999-10-08
ANEROID SPHYGMOMANOMETER (K990638)Genmed, Inc.1999-10-07
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR (K991452)Cobe Cardiovascular, Inc.1999-10-07
CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 (K992575)Infimed, Inc.1999-10-07
0.9% SODIUM CHLORIDE FLUSH SYRINGE (K984590)Baxter Healthcare Corp1999-10-07
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE (K992869)Xomed, Inc.1999-10-07
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) (K993038)Toshiba America Medical Systems, In.C1999-10-07
MODIFICATION TO LINER II: SOFT RELINE LIQUID (K991687)Bosworth Co.1999-10-07
AIRFLOW HANDY (K991857)Electro Medical Systems, Inc.1999-10-07
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS (K992028)Allergan, Inc.1999-10-07
ECG MINIMONITOR, MODEL CG-5000 (K992696)Card Guard Scientific Survival , Ltd.1999-10-07
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 (K990990)Nucletron Corp.1999-10-07
BEACON-P, MODEL 211059 (K992335)Philips Medical Systems (Cleveland), Inc.1999-10-07
EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS (K992450)Emory University1999-10-07
REFERENCE (K992966)Espe Dental AG1999-10-07
INTRODUCER SHEATH, VESSEL DILATOR (K992309)Boston Scientific Corp1999-10-07
BAHO AUTOCLAVABLE CYSTOSCOPE (K992983)Innovative Endoscopy Components, LLC1999-10-07
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA (K991474)Pamitex Industries Sdn Bhd1999-10-06
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C (K992685)Phamatech1999-10-06
SUPER SOOTHER (K991914)Mart Tiller Corp.1999-10-06
LUCITONE FRS FLEXIBEL DENTAL RESIN (K992956)Dentsply Intl.1999-10-06
MODIFICATION TO IMX HOMOCYSTEINE (K992274)Axis Biochemicals, Asa1999-10-06
SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (K992922)Shijiazhuang Hongray Plastic Products Co., Ltd.1999-10-06
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW (K993004)Howmedica Osteonics Corp.1999-10-06
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K993064)Gambro Renal Care Products1999-10-06
REDI-SCREEN (K993100)Redwood Biotech, Inc.1999-10-06
SERAQUEST EB VAC IGM (K990977)Quest Intl., Inc.1999-10-06
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K992861)Shijiazhuang Great Eagle Plastic Products Co., Ltd.1999-10-06
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES (K992782)Nuvasive, Inc.1999-10-05
ALCYON 300I (WITH ISE MODULE) ANALYZER (K993083)Abbott Laboratories1999-10-05
DEXIDE BIPOLAR FORCEPS II** DEVICE (K993055)United States Surgical, A Division of Tyco Healthc1999-10-05
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