Atlas FDA

1994

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

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RecordFirmDate
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY (K943044)Shield Gloves Manufacturer (M) Sdn Bhd1994-09-26
THE OSTEOREPORT (K934040)Woodson and Associates, LLC1994-09-26
DANTEC 13R45 BAR ELECTRODE (K934580)Dantec Medical, Inc.1994-09-26
EPCOR (K930786)Siemens Medical Solutions USA, Inc.1994-09-26
STERIKING, SEE & PEEL (K922440)Cox Sterile Products, Inc.1994-09-26
THE BIOPSY TOOL (K941563)Citation Medical Corp.1994-09-26
PATIENT EXAMINATION GLOVES (K943434)Pacewell Sdn Bhd1994-09-26
QUAD PELVIS COIL (K943321)Hitachi Medical Systems America, Inc.1994-09-23
IRRIGATION/ASPIRATION INSTRUMENT (K942306)Megadyne Medical Products, Inc.1994-09-23
PATLAK & FDG AUTORADIOGRAPHIC (K936001)GE Medical Systems1994-09-23
FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET (K926019)Norland Corp.1994-09-23
DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) (K933445)Storz Instrument Co.1994-09-23
CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS (K934610)Tabex Industries, Inc.1994-09-23
MIRACLE-EAR MIRAGE (K943826)Miracle-Ear, Inc.1994-09-23
SURGICAL INSTRUMENTS AND ACCESSORIES (K942956)Stryker Corp.1994-09-23
VARIAN ORIGAMI, VERSION 1.0 (K932501)Varian Assoc., Inc.1994-09-23
MIRACLE-EAR IMPRESSION MATERIAL KIT (K942523)Miracle-Ear, Inc.1994-09-23
INTERACOUSTICS HEARING AID ANALYZER MS 40 (K943607)Precision Acoustics Ind., Inc.1994-09-23
BIPOLAR ELECTROSURGICAL PENCIL (K943031)Boston Surgical Products, Inc.1994-09-23
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD (K943805)General Electric Co.1994-09-23
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER (K942146)Siemens Medical Solutions USA, Inc.1994-09-23
FORCE GSU-SLPM SYSTEM (K943865)Valleylab, Inc.1994-09-23
VARIAN RMS-2000, RELEASE 2.5 (K930513)Varian Assoc., Inc.1994-09-23
ORIGIN BALLOON ANCHOR (K944304)Origin Medsystems, Inc.1994-09-23
IMPLEX CEMENT RESTRICTOR SYSTEM (K943378)Implex Corp.1994-09-23
VIDEO SCOPE SYSTEM (OTOSCOPE) (K944031)Jedmed Instrument Co.1994-09-23
7250 METABOLIC MONITOR (K924978)Puritan Bennett Corp.1994-09-22
PM-PAGER (K933552)Hill Engineering1994-09-22
MODEL 7200AE VENTILATOR (K922705)Puritan Bennett Corp.1994-09-22
GERITREX STERILE SALINE SOLUTION FOR IRRIGATION (K931509)Geritrex Corp.1994-09-22
CYTOGUIDE STEREOTATIC BIOPSY SYSTEM (K933430)Gold Coast Imaging, Inc.1994-09-22
HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION (K934041)Hewlett-Packard Co.1994-09-22
AUTO-PEEP (K924043)Puritan Bennett Corp.1994-09-22
MODEL 7200AE VENTILATOR (ENHANCEMENT) (K922975)Puritan Bennett Corp.1994-09-22
ADVANCED IN-BED WEIGH SYSTEM (K943587)Future Systems, Inc.1994-09-22
CARDIAC CATHETERIZATION KIT (K932141)Abbott Laboratories1994-09-22
PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD (K930017)Puritan Bennett Corp.1994-09-22
CLOTH TENS/BNES ELECTRODE (K942718)Conmed Andover Medical, Inc.1994-09-22
KSEA CONTINOUS FLOW CYSTOSCOPE (K943668)KARL STORZ Endoscopy-America, Inc.1994-09-21
PRESTERILIZED ENDODONTIC FILES (K943584)Dentsply Intl.1994-09-21
RESOUND PERSONAL HEARING SYSTEM (K943788)Resound Corp.1994-09-21
UROLOGICAL GUIDWIRE (K944135)Applied Medical Resources1994-09-21
ROYAL SHIELD RUBBER DAMS (K942992)Elastomade Accessories Sdn Bhd1994-09-21
REGIONAL ANAESTHESIA TRAY (K932614)Mediziv Medical Products , Ltd.1994-09-21
NIL (K943613)Sing Wah International Enterprises , Ltd.1994-09-21
FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22 (K942579)Valleylab, Inc.1994-09-21
KENDALL MODU-VAC CLOSED SUCTION SYSTEM (K944251)Kendall Healthcare Products Co. Div.Of Tyco Health1994-09-21
MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1 (K942776)Otsuka Electronics USA, Inc.1994-09-21
TAYLOR LONG TERM MONITORING ELECTRODE (K941977)Taylor Industries, Inc.1994-09-21
LIONHEART 3 MULTI-PARAMETER SIMULATOR (K944257)Bio-Tek Instruments, Inc.1994-09-21
MIRACLE EAR CONFIDANTE (K943825)Miracle-Ear, Inc.1994-09-21
SELF TAPPING DENTAL IMPLANT SYSTEM (K933532)Implant Support Systems, Inc.1994-09-21
IMKB CONTRA-ANGLES (K933639)Micro-Mega1994-09-21
3M 1152 LASER IMAGER (K936152)3M Information,Imaging and Electronic Sector1994-09-21
INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM (K936011)Invamed, Inc.1994-09-21
URESIL DILATOR (K942191)Uresil Corp.1994-09-21
XLT, REA COMFORT, SPIREA, ZOOM (K943936)Electric Mobility Corp.1994-09-21
INTEGRITY TOTAL HIP SYSTEM, NON-POROUS (K941486)Kirschner Medical Corp.1994-09-20
P.F.C. CEMENT RESTRICTOR (K942060)Johnson & Johnson Professionals, Inc.1994-09-20
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (K942619)Syva Co.1994-09-20
CROSSFIRE(TM) (705-10650) (K943171)Cardiogenes1994-09-20
INTEGRAL CO-CR FEMORAL COMPONENT (K942479)Biomet, Inc.1994-09-20
FORCEPS, SURGICAL GYNECOLOGICAL (K944055)Owens Precision Systems, Inc.1994-09-20
THE KARL STORZ UROMAT(TM) (K940983)KARL STORZ Endoscopy-America, Inc.1994-09-20
ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS (K935443)Osada Electric Co., Ltd.1994-09-20
AURATEK FDP (K943787)Organon Teknika Corp.1994-09-20
UC QIK 1-STEP HCG TEST (K942464)Eucardio Laboratory, Inc.1994-09-20
CREATININE-PO REAGENT KIT (K943924)Synermed, Inc.1994-09-20
ELIAS CARDIOLIPIN ANTIBODIES (K940403)Elias U.S.A., Inc.1994-09-20
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY (K935393)Bio-Rad Laboratories, Inc.1994-09-20
KT2000 KNEE LIGAMENT ARTHROMETER (K942059)Medmetric Corp.1994-09-20
BINAX LEGIONELLA URINARY ANTIGEN EIA (K934965)Binax, Inc.1994-09-20
THE YELLOW IRIS (K943463)Intl. Remote Imaging Systems1994-09-20
AUTO SUTURE* ANTI-FOG DEVICE** (K944249)United States Surgical, A Division of Tyco Healthc1994-09-20
PROSPECT MICROPLATE ASSAY (K934493)Alexon, Inc.1994-09-20
IMMUNOCARD MYCOPLASMA (K934550)Meridian Diagnostics, Inc.1994-09-20
ACETABULAR DOME HOLE PLUGS (K942809)Osteonics Corp.1994-09-20
KARL STORZ FLUID LIGHT CABLES (K944224)KARL STORZ Endoscopy-America, Inc.1994-09-20
MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (K940426)Medtronic Hemotec, Inc.1994-09-20
SOMATOM PROJECT 059 (K941546)Siemens Corp.1994-09-20
WALLSTENT ESOPHAGEAL PROSTHESIS (K940395)Boston Scientific Scimed, Inc.1994-09-20
GAMMA-BCT INTACT PTH (K942369)Immunodiagnostic Systems , Ltd.1994-09-20
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR (K932595)Johnson & Johnson Orthopaedics, Inc.1994-09-20
VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA (K932411)Med Institute, Inc.1994-09-19
PIONEER LABORATORIES CABLE PIN (K941174)Pioneer Surgical Technology1994-09-19
SHARPS-TAINER SMALL OPENING (K942903)Winfield Co., Inc.1994-09-19
WARMTOUCH PLASTIC WARMING COVER (K943276)Mallinckrodt Medical1994-09-19
BHI AGAR WITH VANCOMYCIN (K941444)Remel Co.1994-09-19
STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT (K925481)Steri-Oss, Inc.1994-09-19
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (K935254)American Diagnostica, Inc.1994-09-19
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT (K942027)Biomet, Inc.1994-09-19
MEDAIR EXCEL 2000 (K942920)Medifloat, Inc.1994-09-19
SHARPS-TAINER LARGE OPENING (K942901)Winfield Co., Inc.1994-09-19
MERCURY EXPIRATORY RESISTANCE EXERCISER (K942919)Mercury Ent., Inc. D/B/A Mercury Medical1994-09-19
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG (K935975)Remel, Inc.1994-09-19
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE (K943022)Cardio Metrics, Inc.1994-09-19
STERI-OSS THREADED TPS HEX SERIES IMPLANT (K925555)Steri-Oss, Inc.1994-09-19
CALCIUM HYDROXIDE PASTE (K943372)Ultradent Products, Inc.1994-09-19
EXAMINATION GLOVES, POWDER FREE (K935384)Jf Trading Co., Ltd.1994-09-19
DISPOSABLE MICROSTAAR INJECTOR (K940593)Staar Sugical1994-09-19
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Every clearance here is in the API, with alerts when new ones post.