Atlas FDA

1995

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

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RecordFirmDate
NEOCAST C, V, S (K950951)Neodontics, Inc.1995-03-23
SABRATEK SABSIL SETS (K944293)Sabratek Corp.1995-03-23
R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 (K944389)R & D Batteries, Inc.1995-03-23
OCIDE HOSPITAL CLEANER-DISINFECTANT (K945227)Clariant Corporation1995-03-23
THE STERN ROOT ANCHOR SYSTEM (K950213)Sterngold/Implamed1995-03-23
HARMONY LINE PF (K950517)Ivoclar North America, Inc.1995-03-23
GALEN (K946334)Medimage, Inc.1995-03-23
DYRACT II RESTORATIVE (K950991)Dentsply Intl.1995-03-23
BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL (K944728)Bioresource Technology, Inc.1995-03-23
PATIENT EXAMINATION GLOVES (K945885)Hartalega Sdn Bhd1995-03-23
DIGITAL 625HF (K950291)Fischer Imaging Corp.1995-03-23
ASPIRE (K936110)Dura Pharmaceuticals, Inc.1995-03-23
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER (K943919)Boston Scientific Corp1995-03-23
ENDOLAP INSUFFLATOR TUBING SET (K950219)Endolap, Inc.1995-03-23
R&D PART NOS. 5490, 5541, 5358, 5497 (K945870)R & D Batteries, Inc.1995-03-23
KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM (K950045)Karl Leibinger GmbH U. Co. KG1995-03-23
1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL (K950131)Therex Corp.1995-03-23
R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 (K944388)R & D Batteries, Inc.1995-03-23
PROSYS URIHESICE SYSTEM NL (K950690)Convatec, A Division of E.R. Squibb & Sons1995-03-23
IMX FOLATE (K943691)Abbott Mfg., Inc.1995-03-23
QUICKPRO BLOOD GLUCOSE TESTING SYSTEM (K944195)Medisense, Inc.1995-03-23
T-GUARD (K945537)Med ET AL Development1995-03-23
IMMULITE C-PEPTIDE (K943767)Diagnostic Products Corp.1995-03-23
PERMALUTE (K950860)Ultradent Products, Inc.1995-03-23
PERMASEAL (K950859)Ultradent Products, Inc.1995-03-23
PRECISION Q I D BLOOD GLUCOSE TEST STRIPS (K945887)Medisense, Inc.1995-03-23
PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL (K945778)Medical Advances, Inc.1995-03-23
KARL STORZ PLASTIC SURGERY ACCESSORIES (K945889)KARL STORZ Endoscopy-America, Inc.1995-03-22
STREAK RETINOSCOPE RX-2 (K950790)Neitz Instruments Company, Ltd.1995-03-22
CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE (K951082)Stephen Chakoff, Inc.1995-03-22
TRACHE-TITE (K950930)The Varner Group, Inc.1995-03-22
INTERWOVEN(TM) REUSABLE SURGICAL GOWN (K945658)Baxter Healthcare Corp1995-03-22
COLDCIDE-2 (K950553)Metrex Research Corp.1995-03-22
HALOGEN DIAGNOSTIC SET BX A - 12345 (K950796)Neitz Instruments Company, Ltd.1995-03-22
DURACON STABILIZER FEMORAL COMPONENT AND INSERT (K932070)Howmedica Corp.1995-03-22
CUSTOM OCULAR PROSTHESIS (K946226)Frank Tanaka, Ocularist, Inc.1995-03-22
SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM (K943593)Ovamed Corp.1995-03-22
COLDCIDE-10 (K950516)Metrex Research Corp.1995-03-22
LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK (K940383)National Laboratories1995-03-22
ULTIMATES SILK GLIDE TAMPONS (K950928)Playtime Products, Inc.1995-03-22
FMS ARTHROSCOPY CANNULA (K945973)Future Medical Systems, Inc.1995-03-22
CHEMOTHERAPY WASTE DISPOSAL CONTAINERS (K943658)Sage Products, Inc.1995-03-22
CHAMP INTERNATIONAL CORP. (K950922)Champ International Corp.1995-03-22
IVALON OPHTHALMIC SPONGE (K946016)Ivalon1995-03-22
GORE-TEX SAM FACIAL IMPLANT (K946267)W. L. Gore & Associates, Inc.1995-03-22
SIGMA 8000 AND SIGMA 8002 (K950766)Sigma Intl. General Medical Apparatus, Inc.1995-03-22
1X6YD, 2X6YD, 4X6YD ROLL BANDAGE (K945002)Certified Safety Mfg., Inc.1995-03-22
SUNGLASSES (K951080)Taiwan Georgia Corp.1995-03-22
XCEL SLIT LAMP (K951054)Leica, Inc.1995-03-22
MULTI-WASH (K950324)Multi-Wash Medical, Ltd.1995-03-22
SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL (K950822)Solopak Laboratories, Inc.1995-03-22
2, 3 & 4 BANDADGE COMPRESS (K945004)Certified Safety Mfg., Inc.1995-03-22
PHLEBOTOMY SHARPS DISPOSAL CONTAINERS (K943660)Sage Products, Inc.1995-03-22
GERTIE MARX NEEDLE (K943649)Manan Medical Products, Inc.1995-03-22
STORZ PREMIERE(R) MICROSURGICAL SYSTEM (K946227)Storz Instrument Co.1995-03-22
MAHURKAR DUAL LUMEN CATHETER (K943349)Quinton, Inc.1995-03-22
INTEC EXTENDED EYE SHIELD WITH MASK (K946343)Intec Industries, Inc.1995-03-22
ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS (K943659)Sage Products, Inc.1995-03-22
DIACIDE HD DISINFECTING SOLUTION (K944037)Gulfstream Medical1995-03-22
CONTROL III DISINFECTANT GERMICIDE (K944179)Maril Products, Inc.1995-03-22
MEDICAL PROCEDURE TRAY, MODIFICATION (K930884)Enpak Medical Corp.1995-03-21
STA SYSTEM CONTROL [N] + [P] KIT (K943518)American Bioproducts Co.1995-03-21
3000 AEROSOL TWO (K943990)Medical Industries America, Inc.1995-03-21
SIEMENS 1481 T TRANSMITTER, ENHANCED (K945037)Siemens Medical Solutions USA, Inc.1995-03-21
X-RAY FILM CASSETTE (K945858)J.P.I. Chicago Co.1995-03-21
HOWMEDICA V40 22MM FEMORAL HEAD (K950541)Howmedica Corp.1995-03-21
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 (K944525)Medical Analysis Systems, Inc.1995-03-21
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)Organon Teknika Corp.1995-03-21
HAPEX MALLEABLE TORP (K950927)Smith & Nephew Richards, Inc.1995-03-21
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS (K950028)Sigma Diagnostics, Inc.1995-03-21
PTT-LT TEST KIT (K941210)American Bioproducts Co.1995-03-21
MEGA-SIL A-B (K950912)Microsonic, Inc.1995-03-21
MAICO IN-THE-EAR MODEL RD-312 CIC (K950637)Maico Hearing Instruments, Inc.1995-03-21
PERCUPUMP II (K932055)E-Z-Em, Inc.1995-03-21
KSEA SEMM TISSUR PUNCH (K943053)Karl Storz Endoskop GmbH1995-03-21
ELX800 AND EL800 AUTOMATED MICROPLATE READERS (K950104)Bio-Tek Instruments, Inc.1995-03-21
URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD (K946116)Chemtech Labs, Inc.1995-03-21
M-29 PP-PC, M-29 PP-O/PC (K950451)Rexton, Inc.1995-03-21
SILICATH ALL SILICONE FOLEY CATHETER (K945806)Unomedical Sdn Bhd1995-03-21
STRATIS (K945386)Hitachi Medical Systems America, Inc.1995-03-21
URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (K950182)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
HORIZON 55 BI-CON TORIC (K950818)Westcon Contact Lens Co., Inc.1995-03-21
BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. (K932779)Birtcher Medical Systems, Inc.1995-03-21
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (K950221)Izon Business Products, Inc.1995-03-21
DYNA 231X (K950758)Phonak, Inc.1995-03-21
FEMROD AND FEMROD RECON INSERT (K935383)Applied Osteo Systems, Inc.1995-03-21
VISUALINE II COCAINE (K950369)Sun Biomedical Laboratories, Inc.1995-03-21
UD 150L-R II (K945453)Shimadzu Medical Systems1995-03-21
SII 525 APR (K950040)Scott Imaging Intl., Inc.1995-03-21
DENTOOL (K923780)Dentool, Inc.1995-03-21
SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY (K950888)Calmed Technology, Inc.1995-03-21
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (K950101)Marquette Electronics, Inc.1995-03-21
SII 360 APR (K950041)Scott Imaging Intl., Inc.1995-03-21
LATEX (K82) (K931746)Diagnostic Products Corp.1995-03-21
CHEM TRAK ACCUMETER (K943599)Chemtrak, Inc.1995-03-21
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (K950134)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (K950427)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
UD 150L-F (K945452)Shimadzu Medical Systems1995-03-21
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER (K945982)KARL STORZ Endoscopy-America, Inc.1995-03-21
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS (K950976)KARL STORZ Endoscopy-America, Inc.1995-03-21
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Every clearance here is in the API, with alerts when new ones post.