Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
WINGED ADMININ. SET W/NON-CORING NEEDLE (K910159)Dmd Products1991-09-06
MEDITRON COMBINATION GENERATOR CG-2000 (K912182)Medical Devices, Inc.1991-09-06
DIGITOXIN (FPIA) KIT (K913240)Tudor Laboratories, Inc.1991-09-06
PIN DOT ALUMINUM PAN (K913548)Pin Dot Products, Inc.1991-09-05
CRYPTOSPORIDIUM ANTIGEN DETECTION (K905598)Lmd Laboratories1991-09-05
MEGA PERICARDIOCENTESIS KIT (K912564)Mega Medical, Inc.1991-09-05
HD-4 CROWN & BRIDGE ALLOY (K905034)Ho Dental Co., Inc.1991-09-05
IMPALA AXLES (K913511)Pin Dot Products, Inc.1991-09-05
WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) (K901619)Wex Medical Instrumentation Co.1991-09-05
ARMREST (K913507)Pin Dot Products, Inc.1991-09-05
CARDIOCAP II(TM) (K912530)Datex Medical Instrumentation, Inc.1991-09-05
PIN DOT GROWTH/DIAL LINKS (K913553)Pin Dot Products, Inc.1991-09-05
PIN DOT TRUNION MOUNTS (K913550)Pin Dot Products, Inc.1991-09-05
WILSON-COOK RUSSELL GASTROSTOMY KIT (K912047)Wilson-Cook Medical, Inc.1991-09-05
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST (K911457)Trimedyne, Inc.1991-09-05
PIN DOT MOUNTING BRACKETS (K913549)Pin Dot Products, Inc.1991-09-05
MASTERPIECES(TM)/MICRO/MINI SYSTEMS (K913289)Storz Instrument Co.1991-09-05
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM (K911625)Heraeus Kulzer, Inc.1991-09-05
PIN DOT FLIP-DOWN ABDUCTOR (K913545)Pin Dot Products, Inc.1991-09-05
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.) (K904446)Acromed Corp.1991-09-05
GS-220 HAND IMPAIRMENT EVALUATION SYSTEM (K912526)J-Tech, Inc.1991-09-05
UNIVERSAL SWIVEL PATCH (K913679)Bryman Medical1991-09-05
IMPALA CASTERS (K913546)Pin Dot Products, Inc.1991-09-05
IMPALA WHEELS (K913509)Pin Dot Products, Inc.1991-09-05
INFUSA D.SLT SYRINGE INFUSION PUMP (K904922)Ferguson Medical1991-09-04
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE (K912518)Convatec, A Division of E.R. Squibb & Sons1991-09-04
LSI SYSTEM II (K904743)M.S.P. , Ltd.1991-09-04
MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER (K910279)New England Medical Instruments, Inc.1991-09-04
IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS (K912531)Innovative Medical Devices, Inc.1991-09-04
INFUSA TS SYRINGE INFUSION PUMP (K904925)Ferguson Medical1991-09-04
STERI-STAT REUSABLE SYRINGE (K910667)David Craig Marketing, Inc.1991-09-04
ADG INTRAMEDULLARY BONE PLUG - VENTED (K911717)American Design Group, Inc.1991-09-04
DRY TIME (K911279)Health Sense Intl., Inc.1991-09-04
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS (K913226)Cardiotronics, Inc.1991-09-04
WARMTOUCH (K913016)Advanced Warming Systems, Inc.1991-09-04
HIGH VOLTAGE PULSED GALVANIC STIMULATION APPLICATI (K910801)Psychoenergetic Systems, Inc.1991-09-04
AUGUSTINE GUIDE(TM) KIT (K912690)Augustine Medical, Inc.1991-09-04
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES (K913223)Medical Device Inspection Co., Inc.1991-09-04
DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS (K912667)Convatec, A Division of E.R. Squibb & Sons1991-09-04
KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A (K913354)Eastman Kodak Company1991-09-04
COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR (K910956)Storz Instrument Co.1991-09-04
KODAK EKTACHEM DTII SYSTEM (K912844)Eastman Kodak Company1991-09-04
CPI MODEL 2215 & SEAMED MODEL 3400 (K912507)Seamed Corp.1991-09-03
ROSYS MODELS 100 AND 200 (K913664)Packard Instrument Co., Inc.1991-08-30
ARTIFICIAL SCLERAL SHELL (K904961)Midwest Eye Laboratories, Inc.1991-08-30
QMS - DIGOXIN (K913562)Seradyn, Inc.1991-08-30
TRANSDUCER PROTECTOR (K912394)Filtertek, Inc.1991-08-30
PATIENT DOSE MONITOR (K912249)Theta Systems, Inc.1991-08-30
EYE ARTIFICIAL CUSTOM (K904962)Midwest Eye Laboratories, Inc.1991-08-30
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM (K911444)Wampole Laboratories1991-08-30
KAPS 90 DEGREE FIBEROPTIC ADAPTOR (K912885)Jedmed Instrument Co.1991-08-30
SCIMED 7 FR. & 8 FR. (K913364)Scimed Life Systems, Inc.1991-08-30
METROLAB MODEL 1500 (K910806)Laboratorio Rodriguez Corswant S.R.L.1991-08-30
LYME-SPOT IF KIT (K910230)Vitek Systems, Inc.1991-08-30
INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET (K913186)Intl. Bioclinical, Inc.1991-08-30
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN (K913229)Baxter Diagnostics, Inc.1991-08-29
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (K912190)Stryker Corp.1991-08-29
API UNISCEPT MIC/UNISCEPT MICRO-MIC (K912964)Analytab Products, Inc.1991-08-29
LP-PLUS (K903774)Fidelity Medical, Inc.1991-08-29
EDENTEC MODEL 3711 DIGITAL RECORDER (K910870)Edentec Corp.1991-08-29
IMPALA (K913512)Pin Dot Products, Inc.1991-08-29
DUKKI (K913544)Pin Dot Products, Inc.1991-08-29
MAJOR SET-UP TRAY (K912159)Medical Device Inspection Co., Inc.1991-08-29
ESCORT 300 SERIES (K911665)Medical Data Electronics1991-08-29
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC (K912263)Zimmer, Inc.1991-08-29
PIN DOT FOOTREST PRODUCTS (K913552)Pin Dot Products, Inc.1991-08-29
EDENTEC DIGITAL CHARTER MODEL 3710 (K910871)Edentec Corp.1991-08-29
STERILE SURGICAL PACK (K904873)Angelica Healthcare Services1991-08-29
ABC LAPAROSCOPIC HANDPROBE (K910889)Birtcher Medical Systems, Inc.1991-08-29
SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER (K912792)Sharplan Lasers, Inc.1991-08-29
EYE TRAY (K912105)Medical Device Inspection Co., Inc.1991-08-29
ARTHROSCOPY TRAY (K912106)Medical Device Inspection Co., Inc.1991-08-29
MASK, SURGICAL APPAREL (K911334)Thai Hospital Products Co., Ltd.1991-08-29
BARD PERIPHERAL BALLOON DILATATION CATHETER (K910822)C.R. Bard, Inc.1991-08-29
VENTROFIL TENSION RELIEF SUTURE SET (K904435)Aesculap, Inc.1991-08-29
GLOBALCARE ELECTRODE (K913373)Globalcare Intl., Inc.1991-08-29
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE (K912739)Site Microsurgical Systems, Inc.1991-08-28
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET (K912439)Hybritech, Inc.1991-08-28
DENTAL CONNECTOR PRECISION ATTACHMENT (K912435)Metalor Dental USA Corp.1991-08-28
BONE MARROW BIOPSY TRAY (K912074)Manan Medical Products, Inc.1991-08-28
SOLITENS MODIFIED (K913522)Innovative Designer Products, Inc.1991-08-28
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 (K905198)Bruel & Kjaer1991-08-28
TRACETS SME 5000 (K912450)Lectec Corp.1991-08-28
PROACT CHOLESTEROL SYSTEMS (K912212)Boehringer Mannheim Corp.1991-08-28
ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM (K912416)Xre Corp.1991-08-28
INTRAVASCULAR ADMINISTRATION SETS (K912860)Pacific Device, Inc.1991-08-28
CANNULA AND TROCAR (K912836)Oceanside Biomedics1991-08-28
MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR (K897068)Medtronic Vascular1991-08-28
100 CM PERMANENT PACING LEAD MODELS (K911273)Telectronics Pacing Systems, Inc.1991-08-28
MICRO-X 15 HF (K912449)Fischer Imaging Corp.1991-08-28
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE (K910924)Pacesetter Systems1991-08-28
ENDOSTAPLE (K911829)ETHICON, Inc.1991-08-28
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (K910609)Biotronik, GmbH & Co.1991-08-28
THE SPRITZ BATH (K912179)The Spritz Co.1991-08-28
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM (K913301)Comet North America, Inc.1991-08-28
FRAMES (EYE GLASSES) (K913046)Jiuh Chyi Ent. Co., Ltd.1991-08-28
THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER (K901281)Val-Mark Medical, Inc.1991-08-28
POLAROID HELIOS LASER IMAGER (K912073)Polaroid Medical Corp.1991-08-28
JMS AV FISTULA NEEDLES (K911199)Jms Co., Ltd.1991-08-28
CSP (K912448)Fischer Imaging Corp.1991-08-28
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.