Atlas FDA

1995

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

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RecordFirmDate
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) (K933784)Immco Diagnostics, Inc.1995-03-07
TRIMPORT (K945250)Gerard Medical Enterprises, Inc.1995-03-07
SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED) (K943254)Wembley Rubber Products (M) Sdn Bhd1995-03-07
FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER (K941692)Rochester Medical Corp.1995-03-06
OSTEONICS RESTORATION MONOLITHIC HIP STEM (K943774)Osteonics Corp.1995-03-06
MANUAL INSTRUMENTS (K943937)Pantheon Surgical Products1995-03-06
TRANSTYMPANIC ENDOSCOPE (K945081)Endooptiks, Inc.1995-03-06
DIASTAT ANTI-PR3 (C-ANCA) KIT (K942813)Shield Diagnostics, Ltd.1995-03-06
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT (K945613)Howmedica Corp.1995-03-06
CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL (K932387)Conceptus, Inc.1995-03-06
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS (K950507)American Hydro-Surgical Instruments, Inc.1995-03-06
LAPAROSCOPE, HAND INSTRUMENTS (K950103)Olympus America, Inc.1995-03-06
CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) (K950748)Stephen Chakoff, Inc.1995-03-06
USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM (K943638)United States Dental Laser, Inc.1995-03-06
RECHARGEABLE BATTERIES (K944521)R & D Batteries, Inc.1995-03-06
RUTNER BIOPSY DEVICE (K950810)Cook Urological, Inc.1995-03-06
PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS (K945209)KARL STORZ Endoscopy-America, Inc.1995-03-06
OLYMPUS BIOPSY FORCEPS MODEL FB-44 (K950786)Olympus America, Inc.1995-03-06
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK (K950027)Intermedics Orthopedics1995-03-06
MITEK THRADED ANCHOR (MTA) (K945203)Mitek Surgical Products, Inc.1995-03-06
PRO BARRIER(TM) TUBE SOX(TM) (K945575)Cottrell, Ltd.1995-03-06
CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE) (K950744)Stephen Chakoff, Inc.1995-03-06
THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM (K941507)Sanese Medical Corp.1995-03-06
CHAKOFF ENDOSCOPY (SET LAPAROSCOPY) (K950746)Stephen Chakoff, Inc.1995-03-06
CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES) (K950745)Stephen Chakoff, Inc.1995-03-06
CLIRANS WET PACK HOLLOW FIBER DIALYZER (K930503)Terumo Medical Corp.1995-03-06
HUMAN PROTEIN C RID TEST KIT (K950015)Jay H. Geller1995-03-06
DIASTAT ANTI-MPO (PANCA) KIT (K943630)Shield Diagnostics, Ltd.1995-03-06
NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA (K946089)American Hydro-Surgical Instruments, Inc.1995-03-06
QUADRA-COIL URETERAL STENT (K946296)Surgitek1995-03-06
MODULAR BIOPSY FORCEP (K946360)Cox Medical Ent., Inc.1995-03-06
UCB (K950689)Cox Medical Ent., Inc.1995-03-06
ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (K944191)Light Diagnostics1995-03-06
ONYX (K943967)Coulter Corp.1995-03-06
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT (K943768)Diagnostic Products Corp.1995-03-06
NEWPORT ELECTRONIC MANOMETER (K941309)Newport Medical Instruments, Inc.1995-03-06
CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) (K950747)Stephen Chakoff, Inc.1995-03-06
R&D PART NOS. 5262, 5543, 5432, 5469 (K945868)R & D Batteries, Inc.1995-03-06
ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (K944192)Light Diagnostics1995-03-06
CANDELA URETHRAL/BLADDER SOUND (K950633)Candela Laser Corp.1995-03-06
RESTORATION HA ACETABULAR CUP SERIES (K943957)Osteonics Corp.1995-03-06
MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (K941534)3M Health Care, Ltd.1995-03-06
CONTROL (K944284)Daig Corp.1995-03-03
MEDX REUSABLE SHARPS CONTAINER (K943771)Bfi- Medical Waste Systems1995-03-03
PRESPO 7, SELF-SUFFICIENT DRIP DEVICE (K933848)Bonding Corp.1995-03-03
SILON(R) SILICONE THERMOPLASTIC SHEETING (K945892)Bio Med Sciences, Inc.1995-03-03
SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS (K944668)Medtronics Interventional Vascular1995-03-03
SCIMED CHIOCE PLUS PTCA GUIDE WIRE (K945129)Scimed Life Systems, Inc.1995-03-03
PREMIER(TM) H. PYLORY (K945558)Meridian Diagnostics, Inc.1995-03-03
LAPAROSCOPE (K950076)Olympus America, Inc.1995-03-03
CK QVET (K950177)Prisma Systems1995-03-03
LUNG DIFFUSION (K942864)Nordan Smith Welding Supplies1995-03-03
SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER (K950094)Scimed Life Systems, Inc.1995-03-03
ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM (K950297)Argus Medical Co., Inc.1995-03-03
MICROPLATE PROCESSOR 3000 (K945135)Organon Teknika Corp.1995-03-03
GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE) (K945953)W. L. Gore & Associates, Inc.1995-03-03
RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE (K945931)Research Industries Corp.1995-03-03
NON-PRESCRIPTION SUNGLASSES (K945922)Csi Industries, Inc.1995-03-03
POWERFLEX(TM) 5F PTA BALLOON CATHETER (K946052)Cordis Corp.1995-03-03
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS (K945494)Boston Scientific Scimed, Inc.1995-03-03
WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (K945877)Wells Johnson Co.1995-03-02
KT1000/S KNEE LIGAMENT ARTHROMETER (K943197)Medmetric Corp.1995-03-02
MEDICAL IMAGE MANAGEMENT SYSTEM (MIM) (K946117)Siemens Medical Solutions Health Services Corporat1995-03-02
HERNIA MESH INTRODUCTION SYSTEM (K945060)Gerard Medical, Inc.1995-03-02
KARL STORZ BOUGIES, SOUNDS, DILATORS (K946331)KARL STORZ Endoscopy-America, Inc.1995-03-02
ORVIS KEY WEST SUNGLASSES (K950609)The Orvis Co., Inc.1995-03-02
POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES (K945767)Ansell, Inc.1995-03-02
DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION (K950608)Lorad Corp.1995-03-02
STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599)Storz Ophthalmics, Inc.1995-03-02
METAL FRAME, PLASTIC FRAME (K945895)Sun Vista Intl., Inc.1995-03-02
V5M (K942296)Acuson Corp.1995-03-02
R&D BATTERIES PART NOS. 5186 AND 5230 (K944387)R & D Batteries, Inc.1995-03-02
SUNGLASSES (K950526)Tony Optical Enterprises Co., Ltd.1995-03-02
605 VACU-MAX (K941961)Medical Industries America, Inc.1995-03-02
ACUSON MODEL 3001 (K935595)Acuson Corp.1995-03-02
SILHOUETTE SUNLIMITED ADIDAS (K950519)Silhouette Optical , Ltd.1995-03-02
S & S ORTHOPEDIC WIRE DRIVER 701 (K944488)S & S Orthopedic , Ltd.1995-03-02
SEALDENT (K944466)Scientific Pharmaceuticals, Inc.1995-03-02
MANAN SUPER-CORE BIOPSY NEEDLE (K950732)Manan Medical Products, Inc.1995-03-02
MODEL IM77 INTRAPARTUM FETAL MONITOR (K940898)Advanced Medical Systems, Inc.1995-03-01
TUNNELER (K943968)Denver Biomedicals, Inc.1995-03-01
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER (K940648)Cordis Corp.1995-03-01
EK-VIEW(TM) ECG MANAGEMENT SYSTEM (K946115)Apcot Medical Systems1995-03-01
SANDBLASTER (K931845)Mirage Dental Systems1995-03-01
NON-PRESCRIPTION SUNGLASSES (K950391)Aceway Sunglasses Corp.1995-03-01
MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES (K945715)Sherwood Medical Co.1995-03-01
KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 (K950091)Konan Medical, Inc.1995-03-01
DMA ALBUMIN PROCEDURE (K946355)Data Medical Associates, Inc.1995-03-01
KIS-II NON-ANGULATED ABUTMENTS (K943984)Implant Center of the Palm Beaches1995-03-01
DOFI RASTER-SCREEN (K943554)Howrey & Simon1995-03-01
POCKET PUMP (K942378)Baxa Infusion Systems1995-03-01
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST (K950307)Princeton BioMeditech Corp.1995-03-01
SURGICAL BUR (K950449)Transidyne General Corp.1995-03-01
BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS (K945832)Brady Medical Products Co.1995-03-01
IMPLANT BODY RETRIEVER/REMOVER (K946113)O Co., Inc.1995-03-01
IMPLANT BODY DEPTH GAUGE/TRYIN (K946129)O Co., Inc.1995-03-01
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (K942700)Critikon Company, LLC1995-03-01
DUMEX WET DRESSINGS (K950132)Dumex Medical Surgical Products, Ltd.1995-03-01
KBTC (K950720)Kyong-Buk Trading Corp.1995-03-01
KIS-II IMPLANT FIXTURES (K943971)Implant Center of the Palm Beaches1995-03-01
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Every clearance here is in the API, with alerts when new ones post.