Atlas FDA

1994

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

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RecordFirmDate
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR (K941048)Applied Osteo Systems, Inc.1994-10-03
ORACLE MRI WHOLE BODY MR IMAGING SYSTEM (K942953)Otsuka Electronics USA, Inc.1994-09-30
4-LEAD IRRIGATION SET (K942101)Douglas Medical Products Corp.1994-09-30
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER (K944090)Candela Laser Corp.1994-09-30
DIGITAL I.D. CAMERA (K942883)Miles Inc., Agfa Division1994-09-30
ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER (K941814)Sherwood Medical Co.1994-09-30
SURGICAL APPAREL (K935199)Associated Hospital Services, Inc.1994-09-30
NO-MES (K935633)Ethox Corp.1994-09-30
HP 77010CF (K943634)Hewlett-Packard Co.1994-09-30
BIOLOGIC DT-1000 MACHINE (K923046)Hemocleanse, Inc.1994-09-30
GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. (K933300)Lyle Howard Corp.1994-09-30
WALLSTENT BILIARY ENDOPROTHESES (K923993)Schneider U.S. Stent Div.1994-09-30
ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (K925405)Synectics-Dantec1994-09-30
CENTRYSYSTEM 3 WITH CHARTS/BP OPTION (K925522)C.G.H. Medical, Inc.1994-09-30
CLEAN-SORB (K941099)Hospital Specialty Co.1994-09-30
WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE (K941958)Western Dialysis Supplies , Ltd.1994-09-30
INTERFERENCE SCREW (K943160)Applied Osteo Systems, Inc.1994-09-30
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS (K925274)Becton Dickinson Immunocytometry Systems1994-09-30
ISOCAM II (DUAL HEAD GAMMA CAMERA) (K940487)Independent Scintilation Imaging Systems, Inc.1994-09-30
IV TRANSFER SPIKE (K943095)Migada, Ltd.1994-09-30
AQUAPLAST TIE DOWN DRESSING (K943871)Wfr/Aquaplast Corp.1994-09-30
CVD BULLETT PERIPHERAL INFUSION CATHETER (K943023)Cardiovascular Dynamics, Inc.1994-09-30
BAXTER CT DIALYZER (K926568)Baxter Healthcare Corp1994-09-30
TECHNA-CUT ASPIRATION NEEDLE (K943651)Manan Medical Products, Inc.1994-09-29
FAMILY FITNESS SHIATSU MASSAGER (K943092)Conair Corp.1994-09-29
CARDIOVASCULAR MEASUREMENT SYSTEM-CMS (K940172)Medis Medical Imaging Systems, Inc.1994-09-29
MASTER ALERT (K934848)Master Hydro Systems, Inc.1994-09-29
ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE (K943807)Shield Gloves Manufacturer (M) Sdn Bhd1994-09-29
LORENZ SURGICAL FINNED DENTAL IMPLANT (K941621)Biomet, Inc.1994-09-29
OHMEDA HAND HELD OXIMETER (K931304)Ohmeda Medical1994-09-29
OHIO CARE PLUS INCUBATOR (K943360)Ohmeda Medical1994-09-29
SONOQUICK ULTRASOUND GEL (K931908)Sonomed Technology, Inc.1994-09-29
EURO TECH MARQUISE CHIROPRACTIC TABLE (K943974)Progressive Electrical Therapeutics1994-09-29
STATLOCK CV (K943147)Venetec, Inc.1994-09-29
ULTIMA UNIPOLAR MODULAR HEAD (K940190)Johnson & Johnson Orthopaedics, Inc.1994-09-29
FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE (K930915)Gebauer Co.1994-09-29
LORENZ SURGICAL CYLINDER DENTAL IMPLANT (K941620)Biomet, Inc.1994-09-29
LORENZ SURGICAL THREADED DENTAL IMPLANT (K941619)Biomet, Inc.1994-09-29
AL-3300 (K940997)Hoya Corp. USA1994-09-29
PODIATRIC MATERIAL (K940132)Crown Delta Corp.1994-09-29
LORDEX LUMBAR EXTENSION MACHINE (K930735)Lordex, Inc.1994-09-29
DISPENSING PIN WITH ONE-WAY VALVE (K943181)B. Braun of America, Inc.1994-09-29
XPERT NCT (K941865)Reichert Ophthalmic Instruments, Div. Leica, Inc.1994-09-29
PHARMASSURE LARGE VOLUME TRANSFER FILTERS (K943127)Gelman Sciences, Inc.1994-09-29
SIEMENS FLUID DELIVERY SYSTEM, MMT-9500 (K933545)Siemens Infusions Systems1994-09-29
GENEMED YAG 1000 MEDICAL LASER (K943479)Genemed, Inc.1994-09-29
FUTURA JUNIOR 300/310 (K943262)Merivaara Instrumentarium Corp.1994-09-29
CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL (K931909)Sonomed Technology, Inc.1994-09-29
KLEIN RECTAL TAMPNADE BALLOON (K933842)Cook Urological, Inc.1994-09-29
SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL (K944617)Unimed Surgical Products, Inc.1994-09-29
GORE-TEX SOFT TISSUE PATCH PLUS (K922452)W. L. Gore & Associates, Inc.1994-09-29
EURO TECH PLATINUM CHIROPRACTIC TABLE (K943975)Progressive Electrical Therapeutics1994-09-29
EURO TECH STERLING ROLLER TABLE (K943973)Progressive Electrical Therapeutics1994-09-29
BETA C COUNTER (K943072)Capintec Instruments, Inc.1994-09-29
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES (K941036)Smith & Nephew, Inc.1994-09-28
SPECTACLE FRAMES (K944373)Custom Optical Frames, Inc.1994-09-28
MANUAL SURGICAL INSTRUMENTS (K942079)Acufex Microsurgical, Inc.1994-09-28
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW (K926417)Alphatec Mfg., Inc.1994-09-28
ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS (K940290)Acufex Microsurgical, Inc.1994-09-28
STANDARD PHACO TIP 15, 30, 45, 60 (K940083)Medical Technical Products1994-09-28
SILHOUETTE, SUNLIMETED,ADIDAS (K944160)Silhouette Optical , Ltd.1994-09-28
WIRELESS CHART PROJECTOR,HCP-W 721 (K936200)Canon USA, Inc.1994-09-28
SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963)Sandhill Scientific, Inc.1994-09-28
PRECISION OSTELOCK SP FEMORAL COMPONENT (K941141)Howmedica Corp.1994-09-28
GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS (K935198)Lake Region Mfg., Inc.1994-09-28
SHIPPERT PRESSURE BANDAGE (K940798)Denver Splint Co.1994-09-28
CARRIER, LIGATURE (79 GEJ) (K944465)Endotec, Inc.1994-09-28
LMT ARTHROSCOPIC SUTURING INSTRUMENTS (K941964)Li Medical Technologies, Inc.1994-09-28
FOUNDATION ALL POLY CUP (K942611)Encore Orthopedics, Inc.1994-09-28
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH (K930623)Boston Scientific Corp1994-09-28
INFINITY REVISION HIP STEM (K942115)Wrightmedicaltechnologyinc1994-09-28
MIC TRANSGASTRIC JEJUNAL TUBE (K926581)Medical Innovations Corp.1994-09-28
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER (K942574)Acufex Microsurgical, Inc.1994-09-28
SUNGLASSES (K941006)Opti-Ray, Inc.1994-09-28
ZEISS OPMI L STEREO-LAPAROSCOPE (K931478)Carl Zeiss, Inc.1994-09-28
AUTOMATIC LENSOMETER (K936199)Canon USA, Inc.1994-09-28
ACUFEX(R) ENDO-FEMORAL AIMER (K942846)Acufex Microsurgical, Inc.1994-09-28
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI (K933014)St. Jude Medical, Inc.1994-09-28
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM (K940283)Medical Concepts, Inc.1994-09-28
ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA (K942834)Acufex Microsurgical, Inc.1994-09-28
P.F.C. CERAMIC HIP HEAD (K933275)Johnson & Johnson Orthopaedics, Inc.1994-09-28
COMPREHENSIVE PHOROPTER, MDR-680 (K936205)Canon USA, Inc.1994-09-28
BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS (K943470)Levtrade Intl. (Pty) , Ltd.1994-09-27
DEKALB (K944414)Endotec, Inc.1994-09-27
CONSENSUS KNEE SYSTEM - PRIMARY KNEE (K932837)U.S. Medical Products, Inc.1994-09-27
SINGLE STICK RADIALLY EXPANDING DILATOR (K943056)Innerdyne Medical, Inc.1994-09-27
SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE (K925333)Aspen Labs1994-09-27
IRRIGATION/BIPOLAR SET (K942944)Surgin Surgical Instrumentation, Inc.1994-09-27
CONBIO CUB-D10 COOPER LASER SYSTEM (K942934)Continuum Biomedical, Inc.1994-09-27
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER (K925143)Pace Medical1994-09-27
BURNFREE BURNSOOTHE HYDROGEL (K943728)Levtrade Intl. (Pty) , Ltd.1994-09-27
PEDI-CAP (K944400)Nellcor, Inc.1994-09-27
LUNG DIFFUSION (K935309)Acetylene Gas Co.1994-09-27
TUBAL LUMEN SUPPORT (K932114)Cook Ob/Gyn1994-09-27
BOUFFANT CAP (K940228)Derekduck Industries Corp.1994-09-26
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM (K943043)Shield Gloves Manufacturer (M) Sdn Bhd1994-09-26
IGM RHEUMATOID FACTOR (K942272)Immco Diagnostics, Inc.1994-09-26
ANTI-RETICULIN ANTIBODY (ARA) TEST (K913360)Immco Diagnostics, Inc.1994-09-26
SURGI-LINK ELECTROSURGICAL ELECTRODE (K944433)Unimed Surgical Products, Inc.1994-09-26
SHOE COVER (K940226)Derekduck Industries Corp.1994-09-26
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Every clearance here is in the API, with alerts when new ones post.