Atlas FDA

1999

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

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RecordFirmDate
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP (K991325)Encore Orthopedics, Inc.1999-06-25
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) (K991053)Astra Tech, Inc.1999-06-25
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM (K991793)AngioDynamics, Inc.1999-06-25
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD (K984508)W&H Dentalwerk Buermoos GmbH1999-06-25
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (K984343)Meridian Diagnostics, Inc.1999-06-25
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (K991587)Helix Medical, Inc.1999-06-25
MAERSK MEDICAL CONTOUR INFUSION SET (K991759)Maersk Medical A/S1999-06-25
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS (K991928)Allegiance Healthcare Corp.1999-06-25
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. (K991610)Zeus Scientific, Inc.1999-06-25
N/T PROTEIN CONTROL LC (K991704)Dade Behring, Inc.1999-06-25
ASH ADVANTAGE PERITONEAL CATHETER (K991042)Janin Group, Inc.1999-06-25
FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION (K991257)Fujifilm Medical System U.S.A., Inc.1999-06-25
INDEPENDENCE 324 (K990484)Eagle Parts & Products, Inc.1999-06-25
FRAMELESS NEUROMATE (K991081)Integrated Surgical Systems, Inc.1999-06-25
TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC (K990020)Te ME NA S.A.R.L.1999-06-24
RENEW LEAD EXTENSION (K991784)Advanced Neuromodulation Systems1999-06-24
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM (K991653)Rymed Technologies, Inc.1999-06-24
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C (K984116)Abatement Technologies, Inc.1999-06-24
CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 (K991891)Ceram Optec, Inc.1999-06-24
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE (K990325)Syntron Bioresearch, Inc.1999-06-24
QUANTEC-E IRRIGATION SYSTEM (K991035)Sybron Dental Specialties, Inc.1999-06-24
LATEX EXAMINATION GLOVES (PRE POWDERED) (K991690)Usg Healthguard Sdn Bhd1999-06-24
MTM BIOSCANNER C TEST STRIPS (K990688)Polymer Technology Systems, Inc.1999-06-24
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS (K991775)Mennen Medical, Inc.1999-06-24
SIEMENS INFINITY EEG POD (K991012)Siemens Medical Solutions USA, Inc.1999-06-24
LATEX EXAMINATION GLOVES (POWDER FREE) (K991689)Usg Healthguard Sdn Bhd1999-06-24
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) (K990876)Brightway Holdings Sdn. Bhd.1999-06-23
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K991749)La Glove (M) Sdn. Bhd.1999-06-23
ACCUTRED SHOE (K991313)Orthopedic Technology Research, Inc.1999-06-23
METACARPAL FIXATION SYSTEM (K991064)Medcanica, Inc.1999-06-23
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K991304)M.R.G. Industries Sdn. Bhd.1999-06-23
DEXIDE BIPOLAR FORCEPS II ** DEVICE (K991859)United States Surgical, A Division of Tyco Healthc1999-06-23
CAPIOX CARDIOPLEGIA (K982467)Terumo Medical Corp.1999-06-23
ORASCOPE (K991011)Fiberdent Corp.1999-06-23
LONGPORT MODEL LDS -1 (K990238)Longport, Inc.1999-06-23
MULTACHOICE INSTRUMENTS (K991814)Dexide, Inc.1999-06-23
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O (K991743)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K991746)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM (K991745)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
EUCLID REDUCTION AND GUIDANCE SYSTEM (K991037)Modular Cutting Systems, Inc.1999-06-23
DEFLECTABLE ELECTROSURGICAL PROBES (K991190)Oratec Interventions, Inc.1999-06-23
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN (K991750)Brightsway Holdings Sdn Bhd1999-06-23
JELTEMP (K991564)J.F. Jelenko & Co., Inc.1999-06-23
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K991752)Brightsway Holdings Sdn Bhd1999-06-23
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G (K991748)La Glove (M) Sdn. Bhd.1999-06-23
DCI ENDOSCOPE (K991228)Karl Storz Endoscopy1999-06-23
MINIMED 407C INFUSION PUMP, MODEL 407C (K991013)Medtronic Minimed1999-06-23
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL (K991021)Nsk Nakanishi, Inc.1999-06-23
SYNTHES QUICK LOCK IMF SYSTEM (K991004)Synthes (Usa)1999-06-23
DCI ENDOSCOPE (K991171)Karl Storz Endoscopy1999-06-23
ACTIWATCH-SCORE (K991033)Mini-Mitter Co., Inc.1999-06-23
HAL SCOPE HOLDER SYSTEM (K991548)Noved Medical1999-06-23
ENDOSCOPIC FIBEROPTIC CABLE (K991208)Isolux America1999-06-23
HYDROTONE-THERMAL CAPSULE SYSTEM (K991184)Nats Corp.1999-06-23
RC BUTTRESS (K991009)Biomet, Inc.1999-06-23
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT (K991744)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
SARGON IMMEDIATE LOAD IMPLANT, MODEL D (K981141)Sargon Ent., Inc.1999-06-23
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI (K984298)Z-Kat, Inc.1999-06-23
CELL-DYN 1200 SYSTEM (K991142)Abbott Laboratories1999-06-23
ROCHE COBAS INTEGRA SERUM BARBITURATES (K991440)Roche Diagnostics Corp.1999-06-22
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 (K991146)Biocheck, Inc.1999-06-22
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 (K991637)Davol Inc., Sub. C. R. Bard, Inc.1999-06-22
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (K991191)Genzyme Surgical Product (Genzyme Biosurgery)1999-06-22
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL (K983344)Dade Behring, Inc.1999-06-22
MODIFICATION TO DIGIPAN (K991912)Trophy Radiologie1999-06-22
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 (K990993)Biocheck, Inc.1999-06-22
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) (K991443)Roche Diagnostics Corp.1999-06-22
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS (K991005)Dayspring Medical, Inc.1999-06-22
IMPACT BALLOON DILATION CATHETER (K983373)B. Braun/Mcgaw1999-06-22
ENDOPATH ENDOSCOPIC INSTRUMENTS (K984240)Ethicon Endo-Surgery, Inc.1999-06-22
NAVIPORT DEFLECTABLE TIP GUIDING CATHETER (K974683)Cardima, Inc.1999-06-22
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 (K991199)Biomed Products1999-06-22
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 (K982950)Chalgren Enterprises, Inc.1999-06-22
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM (K991056)Boston Scientific Corp1999-06-22
PRONTO DRY (K991248)Medical Instruments Corporation Mic AG1999-06-22
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER (K990997)Aktina Medical Physics Corp.1999-06-22
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES (K991305)M.R.G. Industries Sdn. Bhd.1999-06-21
SELF CURE COMPOSITE (K991488)Harry J. Bosworth Co.1999-06-21
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O (K991742)Yty Industry (Manjung) Sdn Bhd1999-06-21
POWDER FREE VINYL EXAMINATION GLOVES (K983856)Shijiazhuang Brethern Plastic Co., Ltd.1999-06-21
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K990186)Shanghai Intco. Plastic & Rubber Products Co., Ltd.1999-06-21
TENDER TOUCH SILICONE GEL PADS (K991478)Capital Marketing Technologies, Inc.1999-06-21
QUANTASE TOTAL GALACTOSE SCREENING ASSAY (K990644)Quantase , Ltd.1999-06-21
POWDERED VINYL EXAMINATION GLOVE (K983893)Shijiazhuang Brethern Plastic Co., Ltd.1999-06-21
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 (K991402)Dako Corp.1999-06-21
IMTEC BIOPIN (K982951)Imtec Corp.1999-06-21
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO (K991513)I-Flow Corp.1999-06-21
FLC COMPOSITE (K991491)Harry J. Bosworth Co.1999-06-21
PACIFIC HEMOSTASIS THROMBOSCREEN 200 (K991321)Pacific Hemostasis1999-06-21
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) (K991362)Morax1999-06-21
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (K991155)C.V. Anlis Abadi International1999-06-21
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (K990654)Quantase , Ltd.1999-06-21
MOUSE IGG1 NEGATIVE CONTROLS (K991454)Dako Corp.1999-06-21
C-FLEX URETERAL STENTS (K991219)Applied Medical Resources1999-06-21
MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\ (K991153)Medtexx Industries (Thai) Co. , Ltd.1999-06-21
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (K990138)Diagnostic Systems Laboratories, Inc.1999-06-21
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR (K990969)Konica Medical Corp.1999-06-18
NORMA 10 (K991243)Odin Technologies , Ltd.1999-06-18
STATUS CUP ACCUSIGN CUP (K991751)Princeton BioMeditech Corp.1999-06-18
GENYX MEDICAL INJECTION NEEDLE (K990996)Genyx Medical, Inc.1999-06-18
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