Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SOLDER AUROLITE REPAIR (K943757)Argen Precious Metals, Inc.1994-09-09
AMSCO STERILE RECOVERIES SURGICAL PACKS (K932522)Amsco Sterile Recoveries, Inc.1994-09-09
CONCORD/PORTEX EPIDURAL CATHETERS (K935927)Smiths Industries Medical Systems, Inc.1994-09-09
B-LACTAMASE REAGENT TUBES (K940161)E-Y Laboratories, Inc.1994-09-09
GONOCHEK-II, MODIFICATION (K934125)E-Y Laboratories, Inc.1994-09-09
KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE (K940594)KARL STORZ Endoscopy-America, Inc.1994-09-09
CINEMAC QAS (K936002)Xre Corp.1994-09-09
PROSPECT GIARDIA (K942098)Alexon, Inc.1994-09-09
CULTURIA MACCONKEY-MUG (K934759)Clinical Convenience Products, Inc.1994-09-09
DUPONT DIMENSION AMYLASE METHOD (K942640)Dupont Medical Products1994-09-09
AVL 988-4 ELECTROLYTE ANALYZER (K943702)Avl Scientific Corp.1994-09-09
EZ-SCREEN:PCP (K943711)Editek, Inc.1994-09-09
GONOCHEK II REAGENT TUBES (K940162)E-Y Laboratories, Inc.1994-09-09
COMBO MASK (K941336)Gam Industries, Inc.1994-09-09
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K942560)Hitachi Medical Systems America, Inc.1994-09-09
SBS MODEL 1615 (K924565)Stand-By-Systems, Inc.1994-09-09
SOLDER AUROLITE CB (K943755)Argen Precious Metals, Inc.1994-09-09
OPTIBOND-D (K943738)Sybron Dental Specialties, Inc.1994-09-09
SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPS (K944045)Unimed Surgical Products, Inc.1994-09-08
OCTOPAQUE UNIVERSAL (K942916)Octostop, Inc.1994-09-08
MS CLASSIQUE BALLOON CATHETER (K943298)Meadox Medicals, Div. Boston Scientific Corp.1994-09-08
AMSCO STERILE RECOVERIES ABSORBENT TOWELS (K931143)Amsco Sterile Recoveries, Inc.1994-09-08
FOLEY CATHETERIZATION TRAY (K942177)Customed, Inc.1994-09-08
MEDI-STIM, MODIFICATION (K933237)Mid-Canada Medical1994-09-08
NAVARRE 600 ML DRAINAGE BAG (K943663)Navarre Biomedical , Ltd.1994-09-08
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (K934741)Clinical Controls, Inc.1994-09-08
DISPOSABLE ESOPHAGEAL STETHOSCOPE (K943495)Coast Medical, Inc.1994-09-08
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM (K934072)Contour Fabricators of Florida, Inc.1994-09-08
LIGHTING SOURCE SYSTEM (K923656)Galenica Enterprises, Inc.1994-09-08
SPIROBAC ADAPTERS (K944124)Mallinckrodt Medical1994-09-08
NON-BALLOON REPLACEMENT GASTROSTOMY KIT (K932295)Biosearch Medical Products, Inc.1994-09-08
INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS (K941688)Innovative Technologies , Ltd.1994-09-08
LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS (K942494)Permeable Technologies, Inc.1994-09-08
ACCESS(R) TOTAL T3 (K940833)Bio-Rad Laboratories, Inc.1994-09-07
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT (K942638)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-09-07
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT (K936079)Exactech, Inc.1994-09-07
SURGICAL DRAPES (K943122)Mallinckrodt Group, Inc.1994-09-07
GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (K933681)Cobe Renal Care, Inc.1994-09-07
MICROCYCLER (K915166)Medical Inventors Corp., Inc.1994-09-07
MAX FRAME DESIGN (K943913)Noble Optic1994-09-07
ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT (K932210)Dow Corning Wright1994-09-07
FREEDOM ASPIRATOR, MODEL 6000 (K944116)Stackhouse, Inc.1994-09-07
SABRE ULTIMATE SHIELDED TROCAR (K943976)Endoscopic Concepts, Inc.1994-09-07
NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION (K934166)Corin Orthopedic Products1994-09-07
CONTINUOUS IRRIGATION CYSTOURETHROSCOPE (K935163)Richard Wolf Medical Instruments Corp.1994-09-07
OCTEIA INTACT PTH (K941878)I.D.S.1994-09-07
MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS (K943958)Tnco, Inc.1994-09-07
STONE EXTRACTOR, GRASPING FORCEPS (K935737)Boston Scientific Corp1994-09-07
CEDIA DAU OPIATE ASSAY (K941195)Microgenics Corp.1994-09-07
UNIPOWER RECHARGEABLE BATTERY PACK (K940842)Unipower Corp.1994-09-07
CUTANEOUS ELECTRODE (K933802)Cadwell Laboratories, Inc.1994-09-07
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT (K941168)Incstar Corp.1994-09-07
INFINITY 252 (K935019)Siemens Hearing Instruments, Inc.1994-09-07
KARL STORZ THORACIC SURGERY INSTRUMENTS (K940427)KARL STORZ Endoscopy-America, Inc.1994-09-07
HUMAN IGG SUBCLASSES ELISA COMBI KIT (K943098)Research Diagnostics, Inc.1994-09-07
HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (K943205)Research Diagnostics, Inc.1994-09-07
VENTANA EMA PRIMARY ANDIBODY (K940243)Ventana Medical Systems, Inc.1994-09-07
HALL MICROCHOICE ELECTRIC POWERED SYSTEM (K942660)Hall Surgical, Division of Zimmer, Inc.1994-09-07
SIEMENS MODEL 584 P-2 (K934752)Siemens Hearing Instruments, Inc.1994-09-07
REVO ROTATOR CUFF REPAIR SYSTEM (K941691)Linvatec Corp.1994-09-06
SPECTACLE FRAMES (K943423)Galilee Optics1994-09-06
ATOMSPEC GF BLOOD LEAD WORKSTATION (K936060)Thermo Jarrell Ash Corp.Div.Thermo Inst.1994-09-06
MODULE PROGRAM (K942722)Electone, Inc.1994-09-06
AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH (K934704)United States Surgical, A Division of Tyco Healthc1994-09-06
PBI PLUS HDL PRECIPITATING REAGENT (K941744)Merchant House Scientific1994-09-06
FLUIDS PACK FOR CORING 238 (K940760)Alko Diagnostic Corp.1994-09-06
VITAL-PORT VASCULAR ACCESS SYSTEM (K934520)Med Institute, Inc.1994-09-06
SYRINGE FILTER DEVICES (K941589)Gelman Sciences, Inc.1994-09-06
SUNGLASSES (K942322)Suntory Industrial Co.1994-09-06
SPECTACLE FRAMES (K943039)Rodenstock USA Inc.,1994-09-06
FULL SPECTRUM ULE FIBER, MODEL FF101 (K920596)Gerald J. Shirk, M.D.1994-09-06
PNEUMATIC WIRE TENSIONER (K942760)Smith & Nephew Richards, Inc.1994-09-06
ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES (K935281)Arbo Medical, Inc.1994-09-06
DELFIA SHBG KIT (K940449)Wallac OY1994-09-06
VIRECTOMY LENS (K940107)Visionary Technologies of Miami, Inc.1994-09-06
OCTOSTOP COMPENSATING FILTERS (K940306)Octostop, Inc.1994-09-06
BODY BOOT (K940723)Mark-Clark1994-09-06
DMA MICROPROTEIN PROCEDURE (K942424)Data Medical Associates, Inc.1994-09-06
DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE (K943970)Cook Ob/Gyn1994-09-06
(BRAND NAME0 MONDAIN (K943840)Chan'S Plastic Manufactory Co., Ltd.1994-09-06
HARPO SUNBED, SUN TANNING MACHINE (K944015)Harpo Industries1994-09-06
TECHNICUFF (K942259)Technicuff Corp.1994-09-06
ELECTRONIC-AMPLIFIED STETHOSCOPE (K941763)Hsues' Brothers Medical, Inc.1994-09-06
BOBBIN STYLE VENTURI VENT TUBE (K943847)Micromed Development Corp.1994-09-02
QUADRASPHERIC FUNDUS LENS (K943125)Volk Optical, Inc.1994-09-02
MEDPOR SURGICAL IMPLANT MATERIAL (K943275)Porex Surgical, Inc.1994-09-02
MRT-150A SHOULDER COIL (K942609)Toshiba America Mri, Inc.1994-09-02
PEMBUSH (K942634)Crossroads Trading Co.1994-09-02
MAGNA SL (K940894)Magna-Lab, Inc.1994-09-02
ROCHE TDM CALIBRATION VERIFICATION TEST SET (K942114)Roche Diagnostic Systems, Inc.1994-09-02
DISPOSABLE, AMBULATORY, INFUSION PUMPS (K940406)Vlv Associates, Inc.1994-09-02
DUOTIP-TEST (K941820)Lincoln Diagnostics, Inc.1994-09-02
AUTO REF-KERATOMETER, RK-3 (K942242)Cannon U.S.A., Inc.1994-09-02
AUDIO EXPERT AUDIOMETER (K942716)Beltone Electronics Corp.1994-09-02
PEREGRINE WIDE ANGLE LIGHT PIPE (K940393)Peregrine Surgical , Ltd.1994-09-02
4 CHANNEL DISPENSER (K942655)Tecan U.S., Inc.1994-09-02
OCTOSTOP(R) CHAIR (NEW MODEL (K935444)Octostop, Inc.1994-09-02
FRAME SPECTACLE (K943753)Optic Tech Corp.1994-09-02
MARQUETTE EAR PROBE SENSOR (K942752)Marquette Electronics, Inc.1994-09-02
PHYSIOTECH 4000 OR NORODYN 8000 (K922270)Myo-Tronics, Inc.1994-09-02
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Every clearance here is in the API, with alerts when new ones post.