Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CHEMMATE(TM) LAMBDA (K950149)Biotek Solutions, Inc.1995-12-06
PROTECTRODE SYSTEM (K926094)The Electrode Store, Inc.1995-12-06
LATEX CONDOM (K941258)Suretex, Ltd.1995-12-06
EMG DISC RECORDING ELECTRODE WITH PIN (K952690)Chalgren Enterprises, Inc.1995-12-06
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT (K934014)Biotrol, USA, Inc.1995-12-06
KUO & YANG SUNGLASSES (K955290)Kuo & Yang Industrial Co., Ltd.1995-12-06
OSOM HCG COMBO TEST (K955141)Wyntek Diagnostics, Inc.1995-12-06
MENSTRUAL TAMPON (K953333)Paragon Trade Brands, Inc.1995-12-06
BELTONE ULTIMA 80 OTOSONIC POWER PAS (K954936)Beltone Electronics Corp.1995-12-06
UNIQUE NEEDLE (K950245)Unique Management Ent., Inc.1995-12-06
UROTRACT I (K955019)Dornier Medtech America, Inc.1995-12-06
J TONGS (K930021)Jerome Medical1995-12-06
RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK) (K944786)Line One Laboratories & Trading Co.1995-12-06
EMG DISC RECORDING ELECTRODE WITH PIN (K952908)Chalgren Enterprises, Inc.1995-12-06
BIOCIDE CLEANER/DISINFECTANT (K934150)Juan Sierra1995-12-06
CRISPICS (K954211)Merlin Engineering Works, Inc.1995-12-05
LIFE SOUND SENSOR AMPLIFIER-LISA (K953833)Flowscan, Inc.1995-12-05
ACCESS CORTISOL ASSAY (MODIFICATION) (K954733)Bio-Rad Laboratories, Inc.1995-12-05
PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM (K954165)Ptw-New York Corp.1995-12-05
RE-BAG MULTI-USE POUCH, LARGE & SMALL (K954185)Miltex, Inc.1995-12-04
RIGID NEUROVIEW ENDOSCOPE (K955037)Neuro Navigational Corp.1995-12-04
CMS ACCUPROBE 550/530 (K953637)Cryomedical Sciences, Inc.1995-12-04
MSV-2000 VIDEO IMAGING SYSTEM (K954160)Applitec, Ltd.1995-12-04
KARL STORZ HEMPFLING DILATION SET (K954981)KARL STORZ Endoscopy-America, Inc.1995-12-04
ANTHOS 2010 READER (K955077)Anthos Labtec, Inc.1995-12-04
VARAPULSE-2 (K952680)Staodyne, Inc.1995-12-04
SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM (K954482)Cirrus Medical,Inc.1995-12-04
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY (K955272)KARL STORZ Endoscopy-America, Inc.1995-12-04
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K945876)Wells Johnson Co.1995-12-04
PROFORM POROUS BEADED FEMORAL STEM (K954466)Stelkast Company1995-12-04
DISCETOME TISSUE ASPIRATOR (K953998)T. Korossurgical Instruments Corp.1995-12-04
REALITY LONG STEM HIP SYSTEM (K954219)Kinamed, Inc.1995-12-04
ROOT CANAL LENGTH MEASURING DEVICE (K953867)J. Morita USA, Inc.1995-12-01
CELSITE VENOUS ACCESS SYSTEM OTW (K954297)B.Braun Medical, Inc.1995-12-01
PULPDENT RESILUTE (K955017)Pulpdent Corp.1995-12-01
FOCUS PC BALLOON DILATATION CATHETER (K954313)Cardio-Dynamics, Inc.1995-12-01
KOWA GENESIS HAND-HELD FUNDUS CAMERA (K954781)Kowa Optimed, Inc.1995-12-01
OPTICAL BLANKS: BENZ55G CLEAR AND VISIBILITY TINTED (K952620)Benz Research and Development Corp.1995-12-01
ORTHOPEDIC PACKS (K951231)Sterile Concepts, Inc.1995-12-01
IMPREGUM PENTA (K954192)Espe GmbH & Co. Kg.1995-12-01
CIRCUIT TREE PHACOEMULSIFIER (K954242)Circuit Tree1995-12-01
DRAGER PT4000 PHOTOTHERAPY SYSTEM (K954611)Drager, Inc.1995-12-01
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C (K954780)Kowa Optimed, Inc.1995-12-01
SURGIN GENISIS PHACOEMULSIFIER (K954241)Surgeon Surgical Instrumentation, Inc.1995-12-01
TITANIUM BIRD BEAK PLIER (K955242)Sybron Dental Specialties, Inc.1995-12-01
EVOLUTION PHACOMULSIFIER (K954240)U.S. Iol, Inc.1995-12-01
ANGIOPTIC ANGIOGRAPHIC CATHETER (K954423)AngioDynamics, Inc.1995-12-01
SYRINGE MAGNIFIER (K953626)Innovative Premiums, Inc.1995-12-01
DEGUBOND X-LITE (K955027)Degussa Corp.1995-12-01
OSTEO-RAY 100 (K953404)Micro Focus Imaging, Inc.1995-11-30
RS-4M (K953136)Rs Medical1995-11-30
CYSTOSCOPE (K941992)Surgical Technologies, Inc.1995-11-30
DAVIS & GECK LIGATING CLIP REMOVER (K953908)Davis & Geck, Inc.1995-11-30
SYNTHASIL APTT REAGENT (K953981)Ortho Diagnostic Systems, Inc.1995-11-30
OSTEONICS UNIPOLAR ENDO HEAD (K954534)Osteonics Corp.1995-11-30
EXTEND HIP SYSTEM (K954288)Wrightmedicaltechnologyinc1995-11-30
PVC ABDOMINAL/RECTAL PRESSURE CATHETER (K954315)Life-Tech Intl., Inc.1995-11-30
PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS (K950602)Reprocessing Products Corp1995-11-30
BD PERISAFE EPIDURAL ANESTHESIA TRAY (K953790)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-11-30
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) (K954711)Nova Biomedical Corp.1995-11-30
SPLASH & GO II (K955295)Kid'S Wheel-Chairs1995-11-30
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM (K953651)Arrow Intl., Inc.1995-11-30
9267 SPO2 ATHENA MODULE (K940933)S & W Medico Teknik1995-11-29
VANGATOR II (K952946)Crow River Industries, Inc.1995-11-29
ICU EXTENSION KIT (K954813)Icu Medical, Inc.1995-11-29
CLS ACETABULAR COMPONENT (MODIFICATION) (K953688)Intermedics Orthopedics1995-11-29
CANYONS BI-DIRECTIONAL CHECK VALVE (K954181)Canyon Medical Products1995-11-29
ACI SINGLE LUMEN BIOPSY NEEDLE (K954264)Advanced Cytometrix, Inc.1995-11-29
WHEEL LEMASTER (K954370)Heliarc Specialists, Inc.1995-11-29
OPTILITE VIII LASER SURGERY ACCESSORIES (K951760)Xintec Corporation1995-11-29
PROLASTIC SHEETING (K954382)Pillar Surgical1995-11-29
ACI FINE NEEDLE ASPIRATION BIOPSY KIT (K954287)Advanced Cytometrix, Inc.1995-11-29
VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR (K955035)Vidamed, Inc.1995-11-29
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) (K954726)Stryker Endoscopy1995-11-29
BLADE, SCALPEL & BLADE, HANDEL (K954536)Access Surgical Intl., Inc.1995-11-29
AM RUBY (K950826)American Lasers, Inc.1995-11-29
TECNOL SALINE WET DRESSING (K954243)Tecnol Medical Products, Inc.1995-11-29
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (K930181)Fresenius USA, Inc.1995-11-29
KELOCOTE (K954413)Allied Biomedical Corp.1995-11-29
ACI PULSATING VACUUM PUMP SYSTEM (K954286)Advanced Cytometrix, Inc.1995-11-29
WAGNER REVISION STEM (MODIFICATION) (K953689)Intermedics Orthopedics1995-11-29
COAT-A-COUNT DIRECT ANDROSTENEDIONE (K954755)Diagnostic Products Corp.1995-11-29
DRS 4 ND DIALYZER REPROCESSING SYSTEM (K944539)Seratronics, Inc.1995-11-29
MYERSON IR DENTURE BASE (K954810)Austenal, Inc.1995-11-29
MLT 20 (K953800)Medical Laser Technology, Inc.1995-11-29
STC DIAGNOSTICS LSD MICRO-PLATE EIA (K954073)Solarcare Technologies Corp,Inc.1995-11-29
OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM (K953961)Osteonics Corp.1995-11-29
DISPOSABLE SYRINGE (K950969)Surgiplast , Ltd.1995-11-29
SPYROFLEX SKIN PROTECTOR (K953885)Polymedica Industries, Inc.1995-11-29
STRATO/INFUSAID INFUSE-A-KIT (K953254)Strato/Infusaid, Inc.1995-11-29
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184)Carbomedics, Inc.1995-11-29
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (K944767)Fresenius USA, Inc.1995-11-29
PROTEAM CUSHION (K953352)Iskra.Med1995-11-29
INTROSCOPE (K953793)Polamedco, Inc.1995-11-29
LIQUICHEK ETHANOL/AMMONIA CONTROL (K955024)Bio-Rad1995-11-28
ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (K952470)R-Group Intl.1995-11-28
GLADIATOR ANTISHOCK PANTS (K953763)Jobst Institute, Inc.1995-11-28
DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS (K954317)Daig Corp.1995-11-28
VACUTAINER BRAND PST PLASMA SEPARATION TUBE (K954592)Becton Dickinson Vacutainer Systems1995-11-28
RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION (K953963)Rusch, Inc.1995-11-27
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Track 1995 automatically

Every clearance here is in the API, with alerts when new ones post.