Atlas FDA

1993

4,167 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KINGS BAY PRELUDE ONE STEP HCG COMBO KIT (K931698)King'S Bay Intl., Inc.1993-11-05
POWERMATIC MAT PLATFORM (K933578)Medical Device Inspection Co., Inc.1993-11-05
GLYCOHEMOGLOBIN (K931183)Teco Diagnostics1993-11-05
NEW STACHROM PROTEIN C TEST KIT (K931906)American Bioproducts Co.1993-11-05
INTERGRAL III DENTAL IMPLANT SYSTEM (K923562)Calcitek, Inc.1993-11-05
OLYMPUS CHLORIDE REAGENT, MODIFICATION (K934136)Olympus Corp.1993-11-05
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET (K934143)Crestat Diagnostics, Inc.1993-11-05
SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE (K925351)Synthes (Usa)1993-11-05
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM (K932467)Instrumentation Laboratory CO1993-11-05
SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY (K932724)Spacelabs Medical, Inc.1993-11-05
POWER WORK TABLE (K933580)Medical Device Inspection Co., Inc.1993-11-05
ACCESS VITAMIN B12 ASSAY (K933142)Bio-Rad Laboratories, Inc.1993-11-05
POWERMATIC TREATMENT TABLE (K933581)Medical Device Inspection Co., Inc.1993-11-05
AMYLASE REAGENT SET (KINETIC) (K931080)Teco Diagnostics1993-11-05
FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR (K930171)Fiberoptic Sensor Technlogies, Inc.1993-11-04
OHMEDA ADAPTABLE CABLE W/DETACHABLE SENSOR (K930081)Ohmeda Monitoring Systems1993-11-04
TALC DISPENSER SYRINGE (K930610)Nusurg, Inc.1993-11-04
ULTRA THIN BALLOON DILATATION CATHETER (K923611)Boston Scientific Corp1993-11-04
DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT (K921713)A and V Ent.1993-11-04
PERIOGLASS (K930115)Usbiomaterials Corp.1993-11-04
OLYMPUS GUIDE WIRE (K933110)Olympus Corp.1993-11-04
LIGHTSPEED DENTAL HAND INSTRUMENT (K932529)Lightspeed Endodontics1993-11-04
DELTAMANAGER (K933321)Medimage, Inc.1993-11-03
FDP - SLIDEX DIRECT (K921989)Biomerieux Vitek, Inc.1993-11-03
TRACHEOSTOMY CARE TRAY (K932016)Clinipad Corp.1993-11-03
QL MULTIPULSE 2048 (K933299)Infimed, Inc.1993-11-03
VICROSAFE 6 AND VICROSAFE 12 (K930041)Buffalo Filter Co., Inc.1993-11-03
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM (K931372)Resound Corp.1993-11-03
DYE MANAGEMENT SYSTEM (K933700)Abbott Laboratories1993-11-03
DURHAM; NON CORING WINGED ADMINISTRATION SET (K931119)Intl. Medical Consultants1993-11-03
CAPS (K932012)Chemichl, Inc.1993-11-03
IMPAX 1000 (K933409)Heraeus Kulzer, Inc.1993-11-03
EP-X (K934481)Fischer Imaging Corp.1993-11-03
RADASSIST (K934566)Diacor, Inc.1993-11-03
DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK (K930974)Intl. Medical Consultants1993-11-03
DUCERAGOLD, DUCERATIN (K931808)Degussa AG1993-11-03
DURHAM;T ADAPTOR EXTENSIONSET W/INJECTION SITE (K930927)Intl. Medical Consultants1993-11-03
MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM (K930579)Medison America, Inc.1993-11-03
ACU-RAY (K931279)Sterne Equipment Co., Ltd.1993-11-03
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY (K933589)Boehringer Mannheim Corp.1993-11-03
RAM-PACS (K933493)Medical Knowledge Systems, Inc.1993-11-03
PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL (K934585)Lafayette Pharmaceuticals, Inc.1993-11-03
CA-1000 AUTOMATED COAGULATION ANALYZER (K931149)Toa Medical Electronics USA, Inc.1993-11-03
ENERGIZED CONTAINER SYSTEM (K925418)Abbott Laboratories1993-11-03
DOCTOR DOWN --RESCUE WRAP (K932539)Three Dog Down1993-11-02
AGGRO/LINK CONTROL SOFTWARE (K932566)Chrono-Log Corp.1993-11-02
SUNGLASSES (K931990)American Eye Way, Inc.1993-11-02
SHARPLAN SHARPLASE LATERAL ND:YAG FIBER (K930582)Sharplan Lasers, Inc.1993-11-02
V-SIL (K933546)Esschem, Inc.1993-11-02
CHILD NONPRESCRIPTION SUNGLASSES (K934308)U.S. Toy Co., Inc.1993-11-02
VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 (K933181)Valleylab, Inc.1993-11-02
TRACTION PRODUCTIONS SPECTACLE FRAMES (K934249)Traction Productions, USA1993-11-02
MODEL #510GE1500 LIVER ARRAY COIL (K933297)Medic, Inc.1993-11-02
ECG GATING UNIT (K931392)Resonex, Inc.1993-11-02
EXTERNAL STABILITY PAD (K932979)Louisville Laboratories, Inc.1993-11-02
WIRE REINFORCED ENDOTRACHEAL TUBE (K932647)Vitaid, Ltd.1993-11-02
OLYMPUS MEASURING DEVICES (K933717)Olympus Corp.1993-11-02
GLASSES (K931451)Siegel Optik1993-11-02
DISCO SUNGLASSES NONPRESCRIPTION SUNGLASSES (K934309)U.S. Toy Co., Inc.1993-11-02
EH-270 CORNEAL TOPOGRAPHER (K933556)Visioptic, Inc.1993-11-02
SORIN MONOLYTH VENOUS RESERVOIR (K933481)Sorin Biomedical, Inc.1993-11-02
BUTTERFLY NONPRESCRIPTION SUNGLASSES (K934307)U.S. Toy Co., Inc.1993-11-02
ANIMAL NONPRESCRIPTION SUNGLASSES (K934304)U.S. Toy Co., Inc.1993-11-02
MULTI-VIEW PROCESSOR (MVP) (K931184)Adac Laboratories1993-11-02
THORACOSCOPE/LAPAROSCOPE (K931954)Surgical Technologies, Inc.1993-11-02
COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE (K933456)Conmedcorp1993-11-02
BURRON CARDIOVASCULAR ANGESTAT(TM) (K931743)B.Braun Medical, Inc.1993-11-02
FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 (K932657)More Diagnostics1993-11-02
BUFFALO FILTER REPLACEMENT #BLFS-101/103 (K930040)Buffalo Filter Co., Inc.1993-11-02
SPRINGFUSOR 10R (K910007)Go Medical Industries Pty. , Ltd.1993-11-02
AVIATOR NONPRESCRIPTION SUNGLASSES (K934305)U.S. Toy Co., Inc.1993-11-02
KENDALL URODYNAMIC CATHETERS (K933399)Kendall Healthcare Products Co. Div.Of Tyco Health1993-11-02
PROMOTIONAL SUNGALSSES (K932416)Associated Premium Corp.1993-11-02
ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES (K933421)L.A.S.E.R., Inc.1993-11-02
BUFFALO FILTER REPLACEMENT FILTER BST312PF (K930061)Buffalo Filter Co., Inc.1993-11-02
AUDIOMETER DA 323 (K933222)Futuremed Div. of Future Impex Corp.1993-11-01
PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS) (K933446)Sudbury Systems, Inc.1993-11-01
AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH (K933597)Arthro-Medic, Inc.1993-11-01
PORTABLE STANDARD (K934263)Cloverleaf Cycle Co.1993-11-01
MODIFIED BRONCHOSCOPE AND ACCESSORIES (K933433)Fujinon, Inc.1993-11-01
MULTITRAK-PLUS (K930894)Zymed Medical Instrumentation1993-11-01
VISIONLINK INTERFILE CONVERSION SOFTWARE (K933372)Evergreen Technologies, Inc.1993-11-01
DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR (K934297)Durable Medical Equipment, Inc.1993-11-01
CARDIO PERFECT, CARDIO PERFECT MD (K922898)Cardio Control BV1993-11-01
ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) (K933543)Jedental Co., Inc.1993-11-01
ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY (K930960)Toshiba America Mri, Inc.1993-11-01
JEDENTAL ZINC CEMENT IMPROVED (K933554)Jedental Co., Inc.1993-11-01
SUR FLO THERMAL THERAPY PADS (K930634)Buckman Co., Inc.1993-11-01
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER (K924452)Baxter Healthcare Corp1993-10-29
ELS 1000 (K933548)Bio-Tek Instruments, Inc.1993-10-29
BUFFALO FILTER REPLACEMENT FILTER #BSTM300 (K930059)Buffalo Filter Co., Inc.1993-10-29
HISTOFREEZER (K933327)Solarcare, Inc.1993-10-29
GORE-TEX MICRO MESH (K931150)W. L. Gore & Associates, Inc.1993-10-29
MICROLINE SCREEN FOR BARBITURATES (K933480)Drug Screening Systems, Inc.1993-10-29
FAN BEAM COLLIMATOR (K933256)Siemens Gammasonics, Inc.1993-10-29
BUFFALO FILTER REPLACEMENT FILTER #BILF-100 (K930450)Buffalo Filter Co., Inc.1993-10-29
PCI 2500 (K933072)Pci1993-10-28
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 (K933437)Baxter Diagnostics, Inc.1993-10-28
SURE-ADAPT NON-ADHERING DRESSING (K933966)Medtrax Industries, Inc.1993-10-28
BACTICARD STREP (K933514)Remel Co.1993-10-28
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Every clearance here is in the API, with alerts when new ones post.