Atlas FDA

1994

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

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RecordFirmDate
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24 (K936062)Hartalega Sdn Bhd1994-06-06
ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH (K941243)Oraline, Ltd.1994-06-06
ANGIOREX CAS-05A (K941177)Toshiba America Medical Systems, In.C1994-06-06
MODEL T131 MEMORY TRANSMITTER (K933021)Biometric Products, Inc.1994-06-06
AMCON SLIP IN MYDRIATIC SUNGLASSES (K942407)Amcon Laboratories, Inc.1994-06-06
DISPOSABLE PROPHY ANGLE (K941009)Allpro, Inc.1994-06-06
OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES (K926594)Owens Industries, Inc.1994-06-06
DISPOSABLE ENT PUNCH (K942065)United States Surgical, A Division of Tyco Healthc1994-06-06
WELCH ALLYN GLAUCOMA DETECTOR (K941723)Welch Allyn, Inc.1994-06-06
VIT CUTTER MODEL 94 (K940746)Visioncare Devices, Inc.1994-06-06
NON-PRESCRIPTION SUNGLASSES (K941432)Large River Industrial Co., Ltd.1994-06-06
MARINR SERIES EP DIAGNOSTIC CATHETERS (K931794)Medtronic Cardiorhythm1994-06-06
DUPONT CRONEX PORTABLE GRID CASSETTE (K941518)Dupont Medical Products1994-06-06
UNIVERSAL INSET PATELLA (K933867)Johnson & Johnson Orthopaedics, Inc.1994-06-06
SUPRA-VIT(TM) (K932669)Medical Instrument Development Laboratories, Inc.1994-06-03
ASSURE URINE HCG CONTROL (K941130)Quantimetrix Corp.1994-06-03
MOUNTAIN SHADES -NONPRESCRIPTION SUNGLASSES (K940741)Mountain Shades, Inc.1994-06-03
DUPONT ACA PLUS PROLACTIN (PROL) METHOD (K941220)Dupont Medical Products1994-06-03
SPECTACLE FRAMES/SUNGLASSES (K941576)Sanders Optical Co., Inc.1994-06-03
SUNGLASSES (K942375)Kool World, Inc.1994-06-03
SUNGLASSES (K934576)Guide Firm , Ltd.1994-06-03
SUNGLASSES (NON-PRESCRIPTION) (K940850)Fantasia Novelty Ent. Corp.1994-06-03
SUNGLASSES (K941875)The Limited Stores, Inc.1994-06-03
TN-RD-50 (K932598)Keithley Instruments, Inc.1994-06-03
SURGICAL SPONGE (K941649)Industries For the Blind & Visually Impaired1994-06-03
KIT,I.V. START (K940035)Mason-Keller Corp.1994-06-03
COATED ZT PROXIMAL SLEEVE (K934412)Joint Medical Products Corp.1994-06-03
I.V. STARTPAK VASCULAR ACCESS START KIT (K942238)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-06-03
FRAMES - VARIOUS BRAND NAMES (K941767)Lenscraft, Inc.1994-06-03
SUNGLASSES (K941296)Three Leaves Industrial Co., Ltd.1994-06-03
CROWN,SKI OPTIC SUNGLASSES (K940947)Sunglass Experts1994-06-03
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 (K942034)R & D Batteries, Inc.1994-06-03
ARTHROSCOPE (K940090)Richard Wolf Medical Instruments Corp.1994-06-03
EDTA GEL (TM) (K940737)Karolinska Institutet1994-06-03
STAT FAX 2600 (K941394)Awareness Technology, Inc.1994-06-03
SUNGLASSES (K941751)The Orvis Co., Inc.1994-06-03
SKI VECTOR NON-PRESCRIPTION SUNGLASSES (K940831)Mountain Shades, Inc.1994-06-03
P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA (K935262)Johnson & Johnson Orthopaedics, Inc.1994-06-03
BE-SAFE (K935843)Mathis-Koolpe, Inc.1994-06-03
SKI VECTOR NON PRECRIPTION SUNGLASSES (K940740)Mountain Shades, Inc.1994-06-03
SUNGLASSES (K941873)Koadak Optical Industrial Co., Ltd.1994-06-03
FOUNDATION POROUS ACETABULAR COMPONENT (K936043)Encore Orthopedics, Inc.1994-06-03
TI-FRAME (K934860)Johnson & Johnson Professionals, Inc.1994-06-03
LACEY ALL POLYETHYLENE TIBIAL COMPONENT (K934354)Dow Corning Wright1994-06-03
MODEL 900GE1500 HEAD/NECK COIL (K940874)Medic, Inc.1994-06-03
EUB-555 (K926209)Hitachi Medical Corp.1994-06-03
SPECTACLE FRAMES (K941602)Slim Occhiali1994-06-03
LIPASE REAGENT SYSTEM (K940457)Medical Diagnostic Technologies, Inc.1994-06-02
APOLIPOPROTIEN B (APO B) (K932603)Sigma Diagnostics, Inc.1994-06-02
ENA EIA TEST KIT (K935413)David A. Fuccillo, Ph.D.1994-06-02
UNISTEP HCG PREGNANCY TEST STRIP (K941090)Biotech Atlantic, Inc.1994-06-02
QMS GENTAMICIN ASSAY (K940376)Seradyn, Inc.1994-06-02
ACCESS PROLACTIN (K941175)Bio-Rad Laboratories, Inc.1994-06-02
BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE (K922481)Board of Directors, Albert Browne , Ltd.1994-06-02
USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 (K940912)U.S. Drug Testing, Inc.1994-06-02
ALEXANTRIPTOR (K940461)Servicetrends, Inc.1994-06-02
BARD(R) EXPANDED PTFE VASCULAR GRAFT (K940816)C.R. Bard, Inc.1994-06-02
QMS CARBAMAZEPINE ASSAY (K940374)Seradyn, Inc.1994-06-02
APOLIPOPROTIEN A-1 (APO A-1) (K932606)Sigma Diagnostics, Inc.1994-06-02
REFLEX EGR (K940955)Ricard-Allan Medical1994-06-02
WAVICIDE MONITOR STRIPS (K932047)Serim Research Corp.1994-06-02
TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES (K940347)KARL STORZ Endoscopy-America, Inc.1994-06-02
MODEL MCC - MKIV MICRO COMPUTER CONTROLS (K940972)Invacare Corp.1994-06-02
CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 (K942199)Rolence Enterprise Co. , Ltd.1994-06-02
CEDIA DAU COCAINE ASSAY (K941310)Microgenics Corp.1994-06-02
NAVIGATOR-MP CATHETER LOCATION INSTRUMENT (K940385)Navion Biomedical Corp.1994-06-02
SOFAMOR ORFIL SPINE FIXATION SYSTEM (K934007)Sofamor Co.1994-06-02
PREDICTOR HOME PREGNANCY TEST (K940637)Organon Teknika Corp.1994-06-02
SBP DENTAL UNIT (K934436)Northland Dental Engineering1994-06-02
ORION SUCTION CATHETER KIT WITH STERILE SALINE (K942274)Regulatory & Marketing Services, Inc.1994-06-02
WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION (K934116)Boston Scientific Scimed, Inc.1994-06-02
ORION SUCTION CATHETER KIT WITH STERILE WATER (K942273)Regulatory & Marketing Services, Inc.1994-06-02
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE (K941305)Wilson-Cook Medical, Inc.1994-06-02
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER (K940269)Hollister, Inc.1994-06-02
LORREX GAUZE SPONGES SPECIALTY (K942314)Lorrex Health Products1994-06-02
KIT PAK INCONTINENT SKIN CARE KIT (K932310)Kit Pak, Inc.1994-06-01
MODEL 26-0375, ELECTROSURGICAL GENERATOR (K931541)Cameron-Miller, Inc.1994-06-01
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM (K940636)Continuum Biomedical, Inc.1994-05-31
NOVAGEL SILICONE GEL SHEETING (K941125)Brennen Medical, Inc.1994-05-31
DMI UTERINE MOBILIZER/ELEVATOR/CANNULA (K931814)Diversified Medical Instruments, Inc.1994-05-31
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES (K941485)Cardio Metrics, Inc.1994-05-31
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM (K940607)Continuum Biomedical, Inc.1994-05-31
TRANSIT INFUSION CATHETER (K936260)Cordis Corp.1994-05-31
SLT FEMORAL HEAD (K932222)Dow Corning Wright1994-05-27
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER (K940422)The Binding Site, Ltd.1994-05-27
REFLEX INS INSUFFLATION NEEDLE (K942207)Richard-Allan Medical1994-05-27
EIDOLON ENDOSCOPE COUPLER (K942141)Eidolon Corp.1994-05-27
ABL5 BLOOD GAS SYSTEM (K935655)Radiometer America, Inc.1994-05-27
IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM (K932123)Implant Innovations International, Inc.1994-05-27
NEBULIZER PUMP, POWERED, MODEL 1110 (K925010)Thomas Industries1994-05-27
H-500 ALLIANCE OXYGEN CONCENTRATOR (K942357)Healthdyne, Inc.1994-05-27
MODIFIED ENDOPATH ILS (K940967)Ethicon Endo-Surgery, Inc.1994-05-27
ORTHO-JET ACRYLIC RESIN - SPARKLE (K941925)Lang Dental Mfg. Co., Inc.1994-05-27
CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS (K940860)Ultradent Products, Inc.1994-05-27
TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM (K940160)Burke Neutech, Inc.1994-05-27
ULTRAFREE-CL (K941326)Millipore Corp.1994-05-27
LORREX GAUZE SPONGES, X-RAY DETECTABLE (K942366)Lorrex Health Products1994-05-27
MODEL 80-1983, ELECTROSURGICAL GENERATOR (K931437)Cameron-Miller, Inc.1994-05-27
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS (K931444)Sorin Biomedica, Fiat, USA, Inc.1994-05-27
REBREATHER BAGS (K940220)Zefon Medical Products1994-05-27
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Every clearance here is in the API, with alerts when new ones post.